FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K962554 |
ABBOTT LABORATORIES |
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE |
11/07/1997 |
K963113 |
ABBOTT LABORATORIES |
FLEXIFLO POLYG GASTOSTOMY TUBE |
10/02/1996 |
K113719 |
ABBOTT LABORATORIES |
SAFETY SCREW CONNECTOR |
04/20/2012 |
K133096 |
ABBVIE INC. |
ABB VIE J |
06/18/2014 |
K142816 |
ABBVIE INC. |
AbbVie J |
01/14/2015 |
K133129 |
ABBVIE INC. |
ABBVIE NJ |
06/19/2014 |
K142792 |
ABBVIE INC. |
AbbVie NJ |
01/14/2015 |
K133087 |
ABBVIE INC. |
ABBVIE PEG |
06/19/2014 |
K142793 |
AbbVie Inc. |
AbbVie PEG |
01/14/2015 |
K112863 |
ACTA MEDICAL L.L.C. |
ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN |
03/29/2012 |
K121571 |
ACTUATED MEDICAL, INC |
TUBECLEAR |
06/13/2012 |
K123659 |
ACTUATED MEDICAL, INC. |
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) |
12/20/2012 |
K163092 |
Actuated Medical, Inc. |
TubeClear Control Box and Clearing Stem |
11/30/2016 |
K131052 |
ACTUATED MEDICAL, INC. |
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) |
08/16/2013 |
K172556 |
Actuated Medical, Inc. |
TubeClear System |
06/29/2018 |
K200646 |
Actuated Medical, Inc. |
TubeClear System |
12/04/2020 |
K092628 |
ALAN REID |
ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET |
05/20/2010 |
K992719 |
AMSINO INTL., INC. |
AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE |
01/12/2000 |
K011077 |
ANDERSEN PRODUCTS, INC. |
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22) |
05/09/2001 |
K021493 |
ANDERSEN PRODUCTS, INC. |
ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S |
08/30/2002 |
K973891 |
APPLIED MEDICAL RESOURCES |
LAPAROSCOPIC GASTROSTOMY KIT |
01/12/1998 |
K971434 |
APPLIED MEDICAL TECHNOLOGIES |
A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE |
08/17/1998 |
K973893 |
APPLIED MEDICAL TECHNOLOGIES |
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE |
12/19/1997 |
K961345 |
APPLIED MEDICAL TECHNOLOGIES |
DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE |
09/17/1996 |
K971757 |
APPLIED MEDICAL TECHNOLOGIES |
LOW PROFILE FEEDING SET ACCESSORY |
11/07/1997 |
K972478 |
APPLIED MEDICAL TECHNOLOGIES |
PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES |
02/09/1998 |
K170319 |
APPLIED MEDICAL TECHNOLOGY INC. |
Low Profile Non-Balloon Feeding Device |
10/06/2017 |
K142971 |
Applied Medical Technology, Inc. |
AMT Bridle - Nasal Tube Retention System |
05/26/2015 |
K980305 |
APPLIED MEDICAL TECHNOLOGY, INC. |
AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE |
04/16/1998 |
K110804 |
APPLIED MEDICAL TECHNOLOGY, INC. |
AMT G-J TUBE |
10/19/2011 |
K073034 |
APPLIED MEDICAL TECHNOLOGY, INC. |
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) |
03/14/2008 |
K042300 |
APPLIED MEDICAL TECHNOLOGY, INC. |
AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM |
10/25/2004 |
K123716 |
APPLIED MEDICAL TECHNOLOGY, INC. |
AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT |
04/19/2013 |
K180026 |
Applied Medical Technology, Inc. |
Bowel Management Device, Bowel Management Irrigation Set |
06/01/2018 |
K161413 |
APPLIED MEDICAL TECHNOLOGY, INC. |
Low Profile Balloon Feeding Device |
02/09/2017 |
K183508 |
Applied Medical Technology, Inc. |
Micro Transgastric-Jejunal Feeding Device |
03/29/2019 |
K012476 |
APPLIED MEDICAL TECHNOLOGY, INC. |
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010 |
08/31/2001 |
K043027 |
APPLIED MEDICAL TECHNOLOGY, INC. |
MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 |
12/02/2004 |
K030784 |
APPLIED MEDICAL TECHNOLOGY, INC. |
NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL |
04/01/2004 |
K202539 |
Applied Medical Technology, Inc. |
Nutriglide(TM) Nasal Feeding Tube |
10/29/2020 |
K182804 |
Applied Medical Technology, Inc. |
Traditional Length GJ Feeding Device |
03/01/2019 |
K142327 |
ART Healthcare Ltd. |
smARTrack Feeding Tube System |
06/08/2015 |
K182248 |
Aspire Bariatrics, Inc |
Aspire Venting Tube |
11/13/2018 |
K180725 |
Aspire Bariatrics, Inc. |
Aspire Introducer Needle |
07/11/2018 |
K220588 |
Avanos Medical Inc |
Avanos* CORTRAK* 2 Enteral Access System (EAS) |
04/22/2022 |
K191340 |
Avanos Medical, Inc. |
CORTRAK* 2 Equilateral Enteral Access System |
06/04/2019 |
K993138 |
BALLARD MEDICAL PRODUCTS |
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT |
10/20/1999 |
K982894 |
BALLARD MEDICAL PRODUCTS |
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT |
09/11/1998 |
K112434 |
BD MEDICAL SURGICAL |
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION |
09/29/2011 |
K131183 |
BENLAN, INC. |
MED-RX ORAL/ENTERAL SYRINGE |
06/03/2014 |
K002838 |
BIOENTERICS CORP. |
GASTRIC SUCTION AND DRAINAGE CATHETER |
07/09/2001 |
K180605 |
Bionix Development Corporation |
GastroFlush |
10/24/2018 |
K130483 |
BOEHRINGER LABORATORIES, LLC |
BOEHRINGER GASTRIC SIZING TUBE |
03/28/2013 |
K081739 |
BOSTON SCIENTIFIC CORP. |
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT |
12/03/2008 |
K020120 |
BOSTON SCIENTIFIC CORP. |
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220 |
08/02/2002 |
K022648 |
BOSTON SCIENTIFIC CORP. |
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521 |
09/05/2002 |
K014297 |
BOSTON SCIENTIFIC CORP. |
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P |
07/09/2002 |
K031538 |
BOSTON SCIENTIFIC CORP. |
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT |
06/27/2003 |
K962375 |
BOSTON SCIENTIFIC CORP. |
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT |
09/04/1996 |
K030855 |
BOSTON SCIENTIFIC CORP. |
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT |
04/17/2003 |
K211072 |
Boston Scientific Corporation |
Safety Trocar Cannula |
04/27/2021 |
K072476 |
Boston Scientific Corporation |
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT |
12/14/2007 |
K012113 |
BOWEL MANAGEMENT SYSTEMS, LLC |
INDWELLING FECAL MANAGEMENT SYSTEM |
05/03/2002 |
K023344 |
BOWEL MANAGEMENT SYSTEMS, LLC |
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE |
11/06/2002 |
K103109 |
C.R. BARD INC |
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE |
12/22/2010 |
K063118 |
C.R. BARD, INC. |
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE |
02/13/2007 |
K991375 |
C.R. BARD, INC. |
BARD BALLOON INFLATION SYSTEM |
09/10/1999 |
K073598 |
C.R. BARD, INC. |
BARD DIGNICARE STOOL MANAGEMENT SYSTEM |
06/13/2008 |
K102391 |
C.R. BARD, INC. |
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM |
12/22/2010 |
K133251 |
C.R. BARD, INC. |
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM |
05/09/2014 |
K013144 |
C.R. BARD, INC. |
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W |
10/19/2001 |
K033562 |
C.R. BARD, INC. |
FASTRAC GASTRIC ACCESS PORT KIT |
12/12/2003 |
K072652 |
CEDIC S.R.L. |
ENTERAL FEEDING SPIKE ADAPTER |
01/18/2008 |
K212444 |
CM Technologies, Inc. |
Qora Stool Management Kit |
11/17/2021 |
K112268 |
CODAN US CORP. |
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR |
03/19/2012 |
K083770 |
COLOPLAST A/S |
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM |
11/23/2009 |
K140310 |
COLOPLAST A/S |
Peristeen Anal Irrigation System |
09/03/2015 |
K103254 |
COLOPLAST A/S |
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE |
01/31/2011 |
K112860 |
COLOPLAST A/S |
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER |
06/08/2012 |
K061021 |
CONMED CORP. |
ENTAKE STANDARD AND SAFETY PEG SYSTEM |
04/28/2006 |
K133465 |
CONSURE MEDICAL PVT LTD. |
CONSURE STOOL MANAGEMENT SYSTEM |
06/26/2014 |
K153506 |
CONSURE MEDICAL PVT LTD. |
Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit |
05/06/2016 |
K162906 |
ConvaTec |
Flexi-Seal PROTECT Fecal Management System |
03/07/2017 |
K112342 |
CONVATEC INC |
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM |
04/26/2012 |
K190114 |
ConvaTec Limited |
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) |
04/30/2019 |
K150350 |
ConvaTec Ltd. |
Flexi-Seal Signal Fecal Management System |
07/21/2015 |
K032734 |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
CONVATEC FECAL MANAGEMENT SYSTEM |
04/08/2004 |
K190084 |
Cook Incorporated |
McLean-Ring Enteral Feeding Tube Set |
10/11/2019 |
K160567 |
COOK INCORPORATED |
Barone Jejunostomy Catheter Set |
05/18/2017 |
K173355 |
Cook Incorporated |
Gastric Sizing Balloon Catheter |
11/17/2017 |
K160509 |
COOK INCORPORATED |
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube |
05/18/2017 |
K982500 |
COOK, INC. |
CHAIT CECOSTOMY CATHETER |
01/27/1999 |
K030841 |
COOK, INC. |
COOK GASTRIC SIZING BALLOON CATHETER |
07/11/2003 |
K935512 |
CORPAK CO. |
CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE |
08/29/1996 |
K990127 |
CORPAK MEDSYSTEMS |
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) |
02/10/1999 |
K133599 |
CORPAK MEDSYSTEMS |
CORGRIP |
03/26/2014 |
K113351 |
CORPAK MEDSYSTEMS |
CORTRAK ENTERAL ACCESS DEVICE |
01/10/2012 |
K091637 |
CORPAK MEDSYSTEMS |
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 |
09/29/2009 |
K131532 |
CORPAK MEDSYSTEMS |
ELECTROMAGNETIC TRANSMITTING STYLET |
08/12/2013 |
K100365 |
CORPAK MEDSYSTEMS |
FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV |
05/20/2010 |
K162110 |
CORPAK MedSystems, Inc. a Division of Haylard Health |
CORGRIP NG/NI Tube Retention System |
09/15/2016 |
K970178 |
CORPAK, INC. |
CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM |
07/21/1997 |
K143088 |
COVIDIEN |
GastriSail Gastric Positioning System |
02/25/2015 |
K123555 |
COVIDIEN |
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY |
04/09/2014 |
K180622 |
Covidien |
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port |
10/23/2018 |
K163002 |
Covidien (dba Medtronic) |
Kangaroo Feeding Tube with IRIS Technology |
05/16/2017 |
K160654 |
Covidien LLC |
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) |
05/04/2016 |
K112511 |
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
DOBBHOFF DUAL PORT FEEDING TUBE |
05/11/2012 |
K221400 |
Creative Balloons GmbH |
hygh-tec drainage |
02/09/2023 |
K110529 |
CROSPON, LTD. |
ENDOFLIP GASTRIC TUBE |
07/22/2011 |
K994300 |
DALE MEDICAL PRODUCTS, INC. |
NASOGASTRIC TUBE HOLDER, MODEL 160 |
02/10/2000 |
K082241 |
DALE MEDICAL PRODUCTS, INC. |
THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 |
10/30/2008 |
K983366 |
DATEX-ENGSTROM, INC. |
TRIP TONOMETRY CATHETER, 16F |
12/23/1998 |
K993296 |
DATEX-OHMEDA, INC. |
TRIP TONOMETRY CATHETER, 14F |
12/15/1999 |
K992181 |
DATEX-OHMEDA, INC. |
TRIP TONOMETRY CATHETER, 8F |
08/24/1999 |
K973409 |
DAVIS & GECK, INC. |
KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS |
02/27/1998 |
K143378 |
DEGANIA SILICONE LTD |
AQUARIUS Gastrostomy Replacement Tube |
12/29/2014 |
K152246 |
DEGANIA SILICONE LTD |
Aquarius Stoma Measuring Device |
06/21/2016 |
K141631 |
DEGANIA SILICONE, LTD. |
AQUARIUS EXTENSION FEEDING SET |
07/28/2014 |
K132686 |
DEGANIA SILICONE, LTD. |
AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE |
05/12/2014 |
K070124 |
DEGANIA SILICONE, LTD. |
GASTROSTOMY REPLACEMENT TUBE, MODEL 253 |
05/23/2007 |
K122030 |
DEGANIA SILICONE, LTD. |
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON |
09/05/2012 |
K170487 |
Dentsply Sirona |
Navina Classic System |
09/11/2017 |
K190977 |
Dentsply Sirona |
Navina Smart System, Navina Classic System |
11/22/2019 |
K082863 |
DYNAREX CORPORATION |
DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) |
01/09/2009 |
K222880 |
Endolumik Inc. |
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) |
03/03/2023 |
K092418 |
ENTRACARE, LLC |
ENTRACARE GASTROSTOMY FEEDING TUBE |
10/23/2009 |
K041034 |
ENTRACARE, LLC |
SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) |
08/31/2004 |
K203133 |
ENvizion Medical Ltd. |
ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube |
03/24/2021 |
K191387 |
Envizion Medical Ltd. |
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube |
06/14/2019 |
K182915 |
ENvizion Medical Ltd. |
ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube |
02/13/2019 |
K090559 |
FOOTPRINT MEDICAL |
FOOTPRINT MEDICAL SILICONE FEEDING TUBE |
05/04/2009 |
K102548 |
FOOTPRINT MEDICAL INC. |
FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE |
11/26/2010 |
K022112 |
FORTUNE MEDICAL INSTRUMENT CORP. |
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 |
04/03/2003 |
K133077 |
GENERICA MEDICAL INTERNATIONAL, INC. |
GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET |
07/28/2014 |
K230206 |
Gravitas Medical, Inc. |
Entarik Feeding Tube System; Entarik Feeding Tube |
03/24/2023 |
K173955 |
Halyard Health, Inc. |
Mic-Key* SF Over-the-Wire Stoma Measuring Device |
01/26/2018 |
K083153 |
HOLLISTER, INC. |
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 |
02/04/2009 |
K100273 |
HOLLISTER, INC. |
INSTAFLO BOWEL CATHETER SYSTEM KIT |
04/22/2010 |
K123804 |
HOLLISTER, INC. |
INSTAFLO BOWEL CATHETER SYSTEM KIT |
04/17/2013 |
K133881 |
HOSPI CORPORATION |
MACY CATHETER |
01/24/2014 |
K061432 |
HOSPIRA, INC. |
HOSPIRA ENTERAL FEEDING SET, MODEL 20640 |
09/11/2006 |
K102712 |
IMED TECHNOLOGY, INC. |
MED GRAVITY SET, IMED PUMP SET |
12/16/2011 |
K042431 |
INCONTINENT CONTROL DEVICES, INC. |
PROCON2 |
05/27/2005 |
K971230 |
INNERDYNE, INC. |
SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT |
06/13/1997 |
K042572 |
KENDALL |
KENDALL CO2NFIRM NOW CO2 DETECTOR |
11/05/2004 |
K120272 |
KENTEC MEDICAL, INC. |
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET |
02/17/2012 |
K043114 |
KIMBERLY-CLARK CORP. |
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE |
12/10/2004 |
K122653 |
KIMBERLY-CLARK CORPORATION |
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES |
06/26/2013 |
K011340 |
LH MEDICAL PRODUCTS, INC. |
LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT |
09/21/2001 |
K011343 |
LH MEDICAL PRODUCTS, INC. |
LH 500 ENTERAL FEEDING GRAVITY BAG SET |
09/21/2001 |
K011341 |
LH MEDICAL PRODUCTS, INC. |
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET |
09/21/2001 |
K083684 |
MANUFACTURING & RESEARCH, INC. |
ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX |
02/05/2009 |
K153461 |
MAQUET CRITICAL CARE AB |
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm |
12/11/2015 |
K101199 |
MAQUET CRITICAL CARE AB |
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, |
08/27/2010 |
K042112 |
MARIAN MEDICAL, INC. |
INFANT FEEDING TUBE |
01/28/2005 |
K961884 |
MARK-CLARK |
CATH CADDIE |
08/01/1996 |
K100366 |
MAXTER CATHETERS |
MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY |
06/14/2010 |
K202748 |
Medcaptain Life Science Co., Ltd. |
Enteral Feeding Catheter |
04/09/2021 |
K013162 |
MEDCOMP |
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH |
10/19/2001 |
K072550 |
MEDEVICE, INC. |
SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301 |
12/07/2007 |
K993358 |
MEDEVICES, INC. |
SIGHTSURE OPERATION INDICATOR, MODEL SS301 |
03/15/2000 |
K970849 |
MEDICAL INFUSION TECHNOLOGIES, INC. |
ENTERAL NUTRITION 1000 ML/500ML |
08/15/1997 |
K142548 |
MEDICAL INNOVATION DEVELOPMENT |
MIDSLEEVE |
06/23/2015 |
K022558 |
MEDICAL INNOVATIVE PRODUCTS |
NGT |
07/08/2003 |
K183577 |
Medline Industries, Inc. |
Medline Quick-Clear Wand |
05/04/2019 |
K031492 |
MOSS MEDICAL PRODUCTS |
MOSSMED DUAL INTERMITTENT ASPIRATOR |
02/05/2004 |
K030413 |
MOSS MEDICAL PRODUCTS |
Y2K2 ENTERNAL FEEDING MANAGER |
05/11/2004 |
K051206 |
MOSS MEDICAL PRODUCTS |
Y2K2 ENTERNAL TUBE FLUID FILTER |
11/02/2005 |
K984628 |
MOSS TUBES, INC. |
MODIFICATION OF MOSS P.E.G. TRAY |
03/17/1999 |
K990389 |
MOSS TUBES, INC. |
MOSS GASTROSTOMY TUBE |
03/22/1999 |
K984310 |
MOSS TUBES, INC. |
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE |
02/24/1999 |
K080328 |
MPS ACACIA |
MPS ACACIA ENTERAL FEEDING TUBE |
05/14/2008 |
K083685 |
MRI MANUFACTURING AND RESEARCH, INC. |
ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 |
06/25/2009 |
K071579 |
N.M. BEALE CO. INC. |
PEF TUBE |
11/20/2007 |
K212407 |
Naser Dib Gabinet Lekarksi Nasmed |
Gastric Lightguide (GLG) |
07/26/2022 |
K212316 |
Nasogastric Feeding Solutions, Ltd. |
DoubleChek DC-1001 |
09/30/2022 |
K983476 |
NAVION BIOMEDICAL CORP. |
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES |
03/01/1999 |
K082710 |
NEOCHILD, LLC |
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET |
01/23/2009 |
K100288 |
NEOMED, INC. |
NEOMED ENTERAL ONLY EXTENSION SET |
08/03/2010 |
K120182 |
NEOMED, INC. |
NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES |
04/19/2012 |
K080340 |
NOVARTIS NUTRITION CORP. |
COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG |
03/05/2008 |
K991668 |
NOVARTIS NUTRITION CORP. |
COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) |
07/26/1999 |
K981323 |
NOVARTIS NUTRITION CORP. |
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE |
10/09/1998 |
K001916 |
NOVARTIS NUTRITION CORP. |
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX |
02/16/2001 |
K071764 |
OBTECH MEDICAL SARL |
REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360 |
10/24/2007 |
K091759 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H |
09/18/2009 |
K051551 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
SMALL INTESTINAL VIDEOSCOPE SYSTEM |
06/28/2005 |
K020005 |
PROMEDIC, INC. |
INFANT FEEDING TUBES |
07/16/2002 |
K072756 |
PROMEDIC, INC. |
NON-IV ADAPTER FOR INFANT NG TUBE |
12/19/2007 |
K052903 |
PROMEDIC, INC. |
PEDIATRIC FEEDING TUBE |
11/09/2005 |
K193325 |
ProSys International Ltd |
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches |
03/13/2020 |
K971901 |
RADIUS INTL., INC. |
RADIUS LOW PROFILE GASTROSTOMY TUBE KIT |
01/22/1998 |
K972025 |
RADIUS INTL., INC. |
RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT |
01/23/1998 |
K972102 |
RADIUS INTL., INC. |
RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT |
01/23/1998 |
K221898 |
ReShape Lifesciences |
Gastrointestinal Boundary Identifier (GIBI HD) |
07/28/2022 |
K220455 |
ReShape Lifesciences |
Lap-Band System Calibration Tube |
06/07/2022 |
K230131 |
ReShape Lifesciences |
ReShape Calibration Tubes |
02/15/2023 |
K082654 |
RESPIRONICS, INC. |
ENTERAL ONLY EXTENSION SET |
11/25/2008 |
K964920 |
RIDGE PRODUCTS, INC. |
RPI DUAL PORT IRRIGATION ADAPTER |
07/09/1997 |
K992494 |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
FLEXIFLO ENTERAL FEEDING TUBE |
08/25/1999 |
K990863 |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE |
04/06/1999 |
K950017 |
ROSS PRODUCTS |
FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM |
03/14/1997 |
K011467 |
ROSS PRODUCTS |
ROSS EMBRACE PUMP SET |
08/10/2001 |
K981203 |
RUSCH INTL. |
RUSCH BLAKEMORE 3 LUMEN, STERILE |
06/05/1998 |
K973892 |
RUSCH INTL. |
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE) |
05/18/1998 |
K010798 |
RUSCH INTL. |
RUSCH CANTOR TUBE |
02/26/2002 |
K010797 |
RUSCH INTL. |
RUSCH MILLER-ABBOTT TUBE |
02/26/2002 |
K102572 |
SAINATH INTELLECTUAL PROPERTIES, LLC |
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT |
12/27/2010 |
K100173 |
SAINATH INTELLECTUAL PROPERTIES, LLC |
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT |
04/16/2010 |
K092049 |
SAINATH INTELLECTUAL PROPERTIES, LLC |
IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT |
10/09/2009 |
K965087 |
SANDOZ NUTRITION |
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) |
03/18/1997 |
K961664 |
SANDOZ NUTRITION |
COMPAT NASOJEJUNAL FEEDING TUBE |
10/04/1996 |
K102741 |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
ENTERAL FEEDING BAG AND SETS |
11/08/2011 |
K954429 |
SHERWOOD MEDICAL CO. |
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT |
03/08/1996 |
K960632 |
SHERWOOD MEDICAL CO. |
KANGAROO FEEDING TUBE PLACMENT STYLET |
05/09/1996 |
K960677 |
SHERWOOD MEDICAL CO. |
KANGAROO JEJUNAL FEEDING SYSTEM |
05/13/1996 |
K070449 |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. |
LUMILOC (TM) SAFETY INTRODUCER NEEDLE |
06/14/2007 |
K191885 |
Standard Bariatrics |
Standard Bougie |
04/08/2020 |
K210437 |
Standard Bariatrics |
Standard Bougie, 38 Fr. |
06/29/2021 |
K212728 |
Standard Bariatrics |
Standard Bougie, 38 Fr. and Hand Pump |
09/23/2021 |
K222085 |
Standard Bariatrics, Inc. |
Standard Tapered Bougie, 38 Fr. |
10/31/2022 |
K072787 |
SYNCRO MEDICAL INNOVATIONS, INC. |
GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 |
10/31/2007 |
K160787 |
SYNCRO MEDICAL INNOVATIONS, INC. |
Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet |
08/09/2016 |
K021991 |
SYNCRO MEDICAL INNOVATIONS, INC. |
MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE |
07/18/2002 |
K110005 |
SYNCRO MEDICAL INNOVATIONS, INC. |
SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE |
08/04/2011 |
K990365 |
T-MED VAC CORPORATION |
GASTRIC LAVAGE VALVE |
07/26/2000 |
K043258 |
TELEFLEX MEDICAL |
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 |
12/16/2004 |
K020379 |
TELEMED SYSTEMS, INC. |
PPD BALLOON DILATATION CATHETER |
05/06/2002 |
K020985 |
TFX MEDICAL, INC. |
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER |
06/25/2002 |
K021034 |
TFX MEDICAL, INC. |
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER |
06/26/2002 |
K132424 |
THE METRIX COMPANY |
METRIXCARE |
02/12/2014 |
K220218 |
Tools for Surgery, LLC |
Siren SGT |
05/18/2022 |
K970890 |
TRI-MED SPECIALTIES, INC. |
#ES-32 SUCTION CATHETER 32 FR. |
05/23/1997 |
K960177 |
UNITED STATES ENDOSCOPY GROUP, INC. |
P.E.G. PATIENT CARE KIT |
03/29/1996 |
K954879 |
UNITED STATES ENDOSCOPY GROUP, INC. |
PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION) |
03/29/1996 |
K954776 |
UNITED STATES ENDOSCOPY GROUP, INC. |
REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY |
01/22/1996 |
K955181 |
UNITED STATES ENDOSCOPY GROUP, INC. |
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE |
06/05/1996 |
K955248 |
UNITED STATES ENDOSCOPY GROUP, INC. |
U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT |
05/21/1996 |
K093653 |
URESIL, LLC |
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK |
02/23/2010 |
K133334 |
VERITRACT, INC. |
VERITRACT ENTERAL FEEDING TUBE SYSTEM |
08/26/2014 |
K043044 |
VIASYS MEDSYSTEMS |
ANTI-I.V. ENTERAL FEEDING SYSTEM |
05/06/2005 |
K041987 |
VIASYS MEDSYSTEMS |
CORTRAK |
12/17/2004 |
K063061 |
VIASYS MEDSYSTEMS |
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 |
04/02/2007 |
K081725 |
VIASYS MEDSYSTEMS |
ENTERAL PUMP SET, MODEL 20-1010 |
11/07/2008 |
K080679 |
VIASYS MEDSYSTEMS |
MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 |
06/27/2008 |
K991918 |
VYGON CORP. |
NUTRISAFE EXTENSION TUBE |
10/29/1999 |
K974806 |
VYGON CORP. |
VYGON NEO-SUMP |
03/23/1998 |
K162340 |
WELL LEAD MEDICAL CO., LTD |
Stomach Tube |
10/11/2017 |
K201322 |
Wilson-Cook Medical, Inc |
Entuit Nasal Jejunal Feeding Tube |
06/17/2020 |
K183336 |
Wilson-Cook Medical, Inc |
Entuit PEG, Entuit PEGJ |
05/29/2019 |
K960415 |
WILSON-COOK MEDICAL, INC. |
WILSON-COOK BALLOON INFLATION DEVICE |
04/26/1996 |
K043203 |
WILSON-COOK MEDICAL, INC. |
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE |
05/11/2005 |
K130611 |
XERIDIEM MEDICAL DEVICES |
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE |
12/19/2013 |
K130674 |
XERIDIEM MEDICAL DEVICES |
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE |
01/13/2014 |
K012147 |
ZEVEX, INC. |
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE |
11/02/2001 |