FDA 510(k) Applications for Medical Device Product Code "ODC"
(Endoscope Channel Accessory)

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


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