FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K192048 |
Anrei Medical (Hangzhou) Co., Ltd. |
Single Use Endoscope Valves Set |
05/14/2020 |
K103155 |
APOLLO ENDOSURGERY, INC. |
SUMO ACCESS AND TISSUE RESECTION SYSTEM |
10/28/2011 |
K970110 |
BARD MEDICAL DIV. |
BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) |
02/19/1997 |
K010610 |
BOSTON SCIENTIFIC CORP. |
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 |
03/27/2001 |
K210353 |
Boston Scientific Corporation |
AutoCap RX |
05/06/2021 |
K090851 |
BYRNE MEDICAL INC. |
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) |
07/02/2009 |
K102409 |
BYRNE MEDICAL INC. |
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 |
11/04/2010 |
K102581 |
BYRNE MEDICAL INC. |
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 |
11/08/2010 |
K110088 |
BYRNE MEDICAL INCORPORATED |
DEFENDO Y-OPSY IRRIGATOR |
06/10/2011 |
K221331 |
Changzhou Endoclean Medical Device Co., Ltd. |
Disposable Endoscope Valves System |
09/08/2022 |
K173105 |
Cook Incorporated |
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter |
03/22/2018 |
K181712 |
Cook Incorporated |
San Antonio Stopcock |
07/26/2018 |
K101094 |
EASYGLIDE LTD. |
CLEARJET |
05/17/2010 |
K160403 |
ENDOCHOICE, INC. |
SmartStart Air/Water and Suction Valves |
05/19/2016 |
K073507 |
EPITEK, INC. |
ANCHORAGE ACCESS KIT |
03/05/2008 |
K073484 |
ETHICON ENDO-SURGERY, INC. |
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 |
03/10/2008 |
K221264 |
FUJIFILM medwork GmbH |
FROG Forceps Valve (VAL1-F1-100) |
06/01/2022 |
K210625 |
FUJIFILM medwork GmbH |
JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve |
09/10/2021 |
K200481 |
GA Health Company Limited |
Andorate Biopsy Valve, Andorate Biopsy Irrigator |
06/18/2020 |
K200495 |
GA Health Company Limited |
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve |
06/24/2020 |
K213095 |
GA Health Company Limited |
andorate Suction Valve, andorate Air/Water Valve |
01/12/2022 |
K202237 |
Hangzhou AGS MedTech Co., Ltd. |
Locking device |
12/23/2020 |
K024301 |
LSI SOLUTIONS |
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT |
03/24/2003 |
K080764 |
MAX ENDOSCOPY INC. |
SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 |
05/06/2008 |
K220247 |
Micro-Tech (Nanjing) Co., Ltd. |
Guidewire Locking Device |
03/29/2022 |
K093329 |
N.M. BEALE CO. INC. |
SCOPE INTRODUCER MODEL 7400 |
02/16/2010 |
K190164 |
Olympus Surgical Technologies America |
CleverLock Guidewire Locking Device and Biopsy Cap |
04/04/2019 |
K110291 |
SMART MEDICAL SYSTEMS, LTD. |
NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE |
06/17/2011 |
K112106 |
SMART MEDICAL SYSTEMS, LTD. |
NAVIAID ICVI-F,S,B,R DEVICE |
02/06/2012 |
K111760 |
SMART MEDICAL SYSTEMS, LTD. |
NAVIAID(TM) BGC DEVICE |
08/09/2011 |
K191231 |
Smartdata Suzhou Co., Ltd |
Andorate Auxiliary Water Connector, Andorate Valves Set |
06/07/2019 |
K220884 |
SML Med-Tech Solutions Limited |
Disposable Endoscope Valve Sets |
01/17/2023 |
K202104 |
Steris Corporation |
BioGuard EUS Air/Water and Suction Valves |
01/14/2021 |
K210342 |
STERIS Corporation |
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor |
09/03/2021 |
K203630 |
STERIS Corporations |
BioGuard Air/Water and Suction Valves |
01/08/2021 |
K192059 |
United States Endoscopy Group, Inc. |
Bio Guard Air/Water & Suction Valves |
09/17/2019 |
K151345 |
UNITED STATES ENDOSCOPY GROUP, INC. |
BioGuard Air/Water Valve, BioGuard Suction Valve |
08/25/2015 |
K112698 |
UNITED STATES ENDOSCOPY GROUP, INC. |
CONCENTRIC BALLOON GOOGLE |
05/18/2012 |
K211814 |
Well Lead Medical CO., LTD. |
Wellead Endoscopic Seal |
01/14/2022 |
K213483 |
Wilson Cook Medical |
SnapLoc Wire Lock |
04/26/2022 |
K200769 |
Wilson Instruments (SHA) Co., LTD |
Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B |
01/06/2021 |
K151714 |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
Disposable Endoscope Valves Set A |
12/03/2015 |
K162142 |
WILSON-COOK MEDICAL, INC. |
Accessory Irrigation Adapter |
04/27/2017 |
K220210 |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Disposable Endoscopy Adapter Set |
06/17/2022 |
K222980 |
Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
Pentax Medical Valve Set |
11/21/2022 |
K192258 |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Disposable Valve Sets |
12/30/2019 |