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Panels › Gastroenterology, Urology › Product code ODC · Class 2

Endoscope Channel Accessory

Regulation 876.1500

1510(k)s in 12 months (72 all time)
3recalls in 12 months (3 all time)
3recalls that name a 510(k)
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Top companies in ODC

Decided510(k)Device and applicantCode
Jun 12, 2026K252933DYNE PORT
Dyne Medical Group, Inc., KR
ODC
Oct 17, 2025K250145Biopsy Port Adapter
Endosound, Inc.
ODC
Oct 9, 2025K252910Orca Air/Water and Suction Valves
Boston Scientific
ODC
Jul 16, 2025K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
Olympus Medical Systems Corporation, JP
ODC
Jun 20, 2025K250732Disposable Endoscopy Valve Set
Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN
ODC
Mar 19, 2025K241842Luer-Split MAJ-2092
Olympus Medical Systems Corporation, JP
ODC
Feb 20, 2025K250140Defendo Fujifilm 700 Single Use Cleaning Adapter
Steris Corparation
ODC
Nov 8, 2024K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
STERIS Corporation
ODC
Oct 11, 2024K242742DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
STERIS Corporation
ODC
Oct 1, 2024K241285Disposable Endoscope Valves Set (AF series)
Alton (Shanghai) Medical Instruments Co., Ltd., CN
ODC
Mar 22, 2024K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm
Medivators (A Subsidiary of Steris Corporation)
ODC
Mar 15, 2024K232327Endorail
Endostart S.R.L., IT
ODC
Mar 6, 2024K240352Defendo Single Use Cleaning Adapter for Olympus Endoscopes
STERIS Corporation
ODC
Mar 6, 2024K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Val
Medivators (A Subsidiary of Steris Corporation)
ODC
Feb 9, 2024K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
STERIS Corporation
ODC
Dec 21, 2023K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Sing
Medivators (A Subsidiary of Steris Corporation)
ODC
Dec 1, 2023K232249PENTAX Medical Gas/Water Feeding Valve OE-B14
Pentax of America, Inc.
ODC
Nov 29, 2023K232244Disposable Endoscope Valves System
Changzhou Endoclean Medical Device Co., Ltd., CN
ODC
Nov 22, 2023K222499Disposable Endoscope Valves Kit
Shanghai SeeGen Photoelectric Technology Co., Ltd., CN
ODC
Oct 20, 2023K232951BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biops
Steris
ODC
Oct 16, 2023K232118ANDORATE® Valve Kit
Ga Health Company Limited, CN
ODC
Jan 17, 2023K220884Disposable Endoscope Valve Sets
Sml Med-Tech Solutions Limited, CN
ODC
Nov 21, 2022K222980Pentax Medical Valve Set
Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN
ODC
Sep 8, 2022K221331Disposable Endoscope Valves System
Changzhou Endoclean Medical Device Co., Ltd., CN
ODC
Jun 17, 2022K220210Disposable Endoscopy Adapter Set
Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN
ODC
Jun 1, 2022K221264FROG Forceps Valve (VAL1-F1-100)
Fujifilm Medwork GmbH, DE
ODC
Apr 26, 2022K213483SnapLoc Wire Lock
Wilson Cook Medical
ODC
Mar 29, 2022K220247Guidewire Locking Device
Micro-Tech (Nanjing) Co., Ltd., CN
ODC
Jan 14, 2022K211814Wellead Endoscopic Seal
Well Lead Medical Co., Ltd., CN
ODC
Jan 12, 2022K213095andorate Suction Valve, andorate Air/Water Valve
Ga Health Company Limited, CN
ODC
Sep 10, 2021K210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
Fujifilm Medwork GmbH, DE
ODC
Sep 3, 2021K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
STERIS Corporation
ODC
May 6, 2021K210353AutoCap RX
Boston Scientific Corporation
ODC
Jan 14, 2021K202104BioGuard EUS Air/Water and Suction Valves
STERIS Corporation
ODC
Jan 8, 2021K203630BioGuard Air/Water and Suction Valves
Steris Corporations
ODC
Jan 6, 2021K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
Wilson Instruments (Sha) Co., Ltd., CN
ODC
Dec 23, 2020K202237Locking device
Hangzhou AGS MedTech Co., Ltd., CN
ODC
Jun 24, 2020K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
Ga Health Company Limited, CN
ODC
Jun 18, 2020K200481Andorate Biopsy Valve, Andorate Biopsy Irrigator
Ga Health Company Limited, CN
ODC
May 14, 2020K192048Single Use Endoscope Valves Set
Anrei Medical (Hangzhou) Co., Ltd., CN
ODC
Dec 30, 2019K192258Disposable Valve Sets
Zhejiang Chuangxiang Medical Technology Co., Ltd., CN
ODC
Sep 17, 2019K192059Bio Guard Air/Water & Suction Valves
United States Endoscopy Group, Inc.
ODC
Jun 7, 2019K191231Andorate Auxiliary Water Connector, Andorate Valves Set
Smartdata Suzhou Co., Ltd., CN
ODC
Apr 4, 2019K190164CleverLock Guidewire Locking Device and Biopsy Cap
Olympus Surgical Technologies America
ODC
Jul 26, 2018K181712San Antonio Stopcock
Cook Incorporated
ODC
Mar 22, 2018K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
Cook Incorporated
ODC
Apr 27, 2017K162142Accessory Irrigation Adapter
Wilson-Cook Medical, Inc.
ODC
May 19, 2016K160403SmartStart Air/Water and Suction Valves
Endochoice, Inc.
ODC
Dec 3, 2015K151714Disposable Endoscope Valves Set A
Wilson Instruments (Shanghai) Company Limited, CN
ODC
Aug 25, 2015K151345BioGuard Air/Water Valve, BioGuard Suction Valve
United States Endoscopy Group, Inc.
ODC

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