FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K082102 |
APOLLO ENDOSURGERY, INC. |
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 |
06/14/2010 |
K122270 |
APOLLO ENDOSURGERY, INC. |
OVERTUBE ENDOSCOPIC ACCESS SYSTEM |
09/28/2012 |
K990775 |
APPLIED MEDICAL RESOURCES |
URETERAL ACCESS SHEATH SET |
04/21/1999 |
K993650 |
APPLIED MEDICAL RESOURCES |
URETERAL ACCESS SHEATH SET - NEW MODELS |
12/28/1999 |
K030642 |
APPLIED MEDICAL RESOURCES CORP. |
DEFLECTING URETERAL ACCESS SHEATH |
05/23/2003 |
K172575 |
BAROnova, Inc. |
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap |
01/18/2018 |
K082589 |
BAROSENSE, INC |
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 |
05/22/2009 |
K120126 |
BAROSENSE, INC |
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE |
09/10/2012 |
K122565 |
BODDINGTONS PLASTICS LTD |
ARC ENDOCUFF |
09/04/2012 |
K162205 |
BODDINGTONS PLASTICS LTD |
Arc EndoCuff and Arc EndoCuff Vision |
12/09/2016 |
K191067 |
Boddingtons Plastics Ltd |
Arc Endocuff Glide AEG110 & AEG120 |
05/30/2019 |
K151801 |
BODDINGTONS PLASTICS LTD |
Arc Endocuff Vision |
08/13/2015 |
K140323 |
BOSTON SCIENTIFIC |
NAVIGATOR HD URETERAL ACCESS SHEATH SETS |
03/07/2014 |
K173400 |
Boston Scientific |
ORISE Tissue Retractor System |
02/09/2018 |
K122649 |
BOSTON SCIENTIFIC CORP. |
NAVIGATOR HD URETERAL ACCESS SHEATH SET |
12/12/2012 |
K030956 |
BOSTON SCIENTIFIC CORP. |
NAVIGATOR URETERAL ACCESS SHEATH SET |
05/23/2003 |
K051504 |
BOSTON SCIENTIFIC CORP. |
SPYSCOPE ACCESS AND DELIVERY CATHETER |
06/16/2005 |
K030438 |
C.R. BARD, INC. |
BARD AQUAGUIDE URETERAL CONDUIT |
03/17/2003 |
K973500 |
C.R. BARD, INC. |
BARD ENDOSCOPIC OVERTUBE (#000307) |
10/16/1997 |
K033778 |
C.R. BARD, INC. |
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT |
12/30/2003 |
K160861 |
C.R. Bard, Inc. |
Proxis Ureteral Access Sheath |
03/31/2016 |
K150083 |
C2 THERAPEUTICS |
Sidecar External Working Channel |
04/14/2015 |
K102485 |
COLOPLAST A/S |
RE-TRACE URETERAL ACCESS SHEATH |
10/18/2010 |
K123675 |
COLOPLAST A/S |
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR |
03/01/2013 |
K140523 |
COLOPLAST A/S |
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM |
07/24/2014 |
K181811 |
Coloplast A/S |
ReTrace Ureteral Access Sheath |
09/07/2018 |
K983415 |
CONWAY STUART MEDICAL, INC. |
DELIVERY SHEATH |
12/01/1998 |
K172217 |
Cook Incorporated |
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath |
12/13/2017 |
K182403 |
Cook Incorporated |
Peel-Away Introducer |
05/29/2019 |
K043418 |
COOK UROLOGICAL, INC. |
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH |
03/31/2005 |
K110531 |
CROSPON, LTD. |
ENDOFLIP ECD |
10/06/2011 |
K201815 |
Dornier MedTech America Inc |
Dornier MAGELLAN Ureteral Access Sheath |
11/20/2020 |
K133359 |
ENDO-AID, INC. |
ENDORINGS |
02/11/2014 |
K230752 |
Fujifilm Healthcare Americas Corporation |
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) |
09/15/2023 |
K091773 |
FUJINON, INC. |
FUJINON STERILE OVERTUBES |
08/07/2009 |
K192691 |
H&A Mui Enterprises Inc. |
PatCom Single-Use Introducer |
02/21/2020 |
K200419 |
Kalera Medical, Inc. |
Kalera Vacuum Aspiration Catheter (K-VAC) |
05/22/2020 |
K022686 |
LAP SURGICAL SYSTEMS, LLC |
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE |
11/25/2002 |
K160846 |
MEDIVATORS, INC. |
AmplifEYE |
07/14/2016 |
K190030 |
Micro-Tech (Nanjing) Co., Ltd. |
Embrella Endoscopic Distal Attachment |
03/05/2019 |
K211301 |
Neptune Medical, Inc. |
Pathfinder Endoscope Overtube |
05/28/2021 |
K191415 |
Neptune Medical, Inc. |
Pathfinder Endoscope Overtube |
08/30/2019 |
K230801 |
Neptune Medical, Inc. |
Pathfinder Endoscope Overtube with Balloon Device |
07/28/2023 |
K123013 |
NOVADAQ TECHNOLOGIES, INC. |
ENDOSCOPIC INTRODUCER |
03/22/2013 |
K972781 |
PRISM THERAPEUTICS, LLC. |
OT-1 |
09/19/1997 |
K061324 |
RTC INC.-MEMCATH TECHNOLOGIES LLC |
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 |
06/20/2006 |
K092156 |
SOFTSCOPE MEDICAL TECHNOLOGIES, INC. |
CAD 12, COLONOSCOPY ASSIST DEVICE |
10/14/2009 |
K052084 |
SPIRUS MEDICAL, INC. |
ENDO-EASE ENDOSCOPIC OVERTUBE |
09/14/2005 |
K062805 |
SPIRUS MEDICAL, INC. |
MODIFICATION TO ENDO-EASE |
10/13/2006 |
K080050 |
SPIRUS MEDICAL, INC. |
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE |
05/06/2008 |
K182520 |
Sumitomo Bakelite Co., Ltd |
Flexible Overtube |
05/15/2019 |
K002018 |
SURGICAL, INC. |
NDO SURGICAL SURGICAL OVERTUBE |
08/17/2000 |
K203165 |
Suzhou Beyo Medical Technology Co., Ltd. |
Disposable Ureteral Access Sheath |
04/30/2021 |
K200770 |
Trokamed GmbH |
Mini PCNL-System |
07/30/2021 |
K131598 |
UNITED STATES ENDOSCOPY GROUP, INC. |
ANAL RECTAL OVERTUBE |
02/26/2014 |
K092221 |
UNITED STATES ENDOSCOPY GROUP, INC. |
COLONIC SPLINTING OVERTUBE, MODEL 00711145 |
10/20/2009 |
K040836 |
UNITED STATES ENDOSCOPY GROUP, INC. |
DISPOSABLE OVERTUBE |
06/10/2004 |
K100081 |
UNITED STATES ENDOSCOPY GROUP, INC. |
ENTEROSCOPY OVERTUBE, MODEL 00712140 |
04/12/2010 |
K051919 |
USGI MEDICAL |
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE |
07/26/2005 |
K050253 |
USGI MEDICAL |
USGI SHAPELOCK ENDOSCOPIC GUIDE |
02/28/2005 |
K072405 |
USGI MEDICAL |
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE |
09/13/2007 |
K061216 |
USGI MEDICAL |
USGI TRANSPORT ENDOSCOPIC GUIDE |
05/15/2006 |
K033954 |
USGI MEDICAL, INC. |
SHAPE LOCKING ENDOSCOPIC OVERTUBE |
03/19/2004 |
K023902 |
USGI MEDICAL, INC. |
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE |
08/20/2003 |
K171208 |
Visionsense Ltd. |
Trans-anal Introducer |
02/05/2018 |
K151084 |
WELL LEAD MEDICAL CO. LTD |
Well Lead Ureteral Access Sheath |
01/07/2016 |
K203119 |
Well Lead Medical Co., LTD. |
ClearPetra Suction-Evacuation Sheath |
12/09/2020 |
K161110 |
WELL LEAD MEDICAL CO., LTD. |
ClearPetra Suction-Evacuation Sheath |
10/12/2016 |
K230748 |
YouCare Technology Co., Ltd. (Wuhan) |
Disposable Ureteral Access Sheath |
08/02/2023 |
K220065 |
Zhejiang Chuangxiang Medical Technology Co., Ltd. |
Single Use Ureteral Access Sheath |
05/25/2022 |