FDA 510(k) Applications for Medical Device Product Code "ODC"
(Endoscope Channel Accessory)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K241285 | Alton (Shanghai) Medical Instruments Co. Ltd | Disposable Endoscope Valves Set (AF series) | 10/01/2024 |
| 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 |
| K232244 | Changzhou Endoclean Medical Device Co., Ltd. | Disposable Endoscope Valves System | 11/29/2023 |
| 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 |
| K232327 | Endostart s.r.l. | Endorail | 03/15/2024 |
| 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 |
| K232118 | GA Health Company Limited | ANDORATE« Valve Kit | 10/16/2023 |
| 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 |
| K232067 | Medivators (A Subsidiary of STERIS Corporation) | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector | 03/22/2024 |
| K232329 | Medivators (A Subsidiary of STERIS Corporation) | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter | 12/21/2023 |
| K232004 | Medivators (A Subsidiary of STERIS Corporation) | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector | 03/06/2024 |
| 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 |
| K241842 | Olympus Medical Systems Corporation | Luer-Split MAJ-2092 | 03/19/2025 |
| K250949 | Olympus Medical Systems Corporation | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | 07/16/2025 |
| K190164 | Olympus Surgical Technologies America | CleverLock Guidewire Locking Device and Biopsy Cap | 04/04/2019 |
| K232249 | PENTAX of America, Inc. | PENTAX Medical Gas/Water Feeding Valve OE-B14 | 12/01/2023 |
| K222499 | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Disposable Endoscope Valves Kit | 11/22/2023 |
| 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 |
| K232951 | Steris | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield | 10/20/2023 |
| K250140 | STERIS Corparation | Defendo Fujifilm 700 Single Use Cleaning Adapter | 02/20/2025 |
| 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 |
| K240352 | STERIS Corporation | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | 03/06/2024 |
| K243075 | Steris Corporation | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | 11/08/2024 |
| K240098 | Steris Corporation | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | 02/09/2024 |
| K242742 | STERIS Corporation | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | 10/11/2024 |
| 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 |
| K250732 | Yangzhou Fartley Medical Instrument Technology Co,. Ltd | Disposable Endoscopy Valve Set | 06/20/2025 |
| 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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