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)
Top companies in ODC
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 7 | 0 |
| Boston Scientific | 3 | 1 |
| Byrne Medical Incorporated | 4 | 0 |
| Ga Health Company Limited | 4 | 0 |
| Medivators (A Subsidiary of Steris Corporation) | 3 | 0 |
| Smart Medical Systems , Ltd. | 3 | 0 |
| United States Endoscopy Group, Inc. | 3 | 0 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 3 | 0 |
| Changzhou Endoclean Medical Device Co., Ltd. | 2 | 0 |
| Cook Incorporated | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2026 | K252933 | DYNE PORT Dyne Medical Group, Inc., KR | ODC |
| Oct 17, 2025 | K250145 | Biopsy Port Adapter Endosound, Inc. | ODC |
| Oct 9, 2025 | K252910 | Orca Air/Water and Suction Valves Boston Scientific | ODC |
| Jul 16, 2025 | K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) Olympus Medical Systems Corporation, JP | ODC |
| Jun 20, 2025 | K250732 | Disposable Endoscopy Valve Set Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | ODC |
| Mar 19, 2025 | K241842 | Luer-Split MAJ-2092 Olympus Medical Systems Corporation, JP | ODC |
| Feb 20, 2025 | K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter Steris Corparation | ODC |
| Nov 8, 2024 | K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) STERIS Corporation | ODC |
| Oct 11, 2024 | K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) STERIS Corporation | ODC |
| Oct 1, 2024 | K241285 | Disposable Endoscope Valves Set (AF series) Alton (Shanghai) Medical Instruments Co., Ltd., CN | ODC |
| Mar 22, 2024 | K232067 | Defendo 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, 2024 | K232327 | Endorail Endostart S.R.L., IT | ODC |
| Mar 6, 2024 | K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes STERIS Corporation | ODC |
| Mar 6, 2024 | K232004 | Defendo 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, 2024 | K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) STERIS Corporation | ODC |
| Dec 21, 2023 | K232329 | Defendo 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, 2023 | K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 Pentax of America, Inc. | ODC |
| Nov 29, 2023 | K232244 | Disposable Endoscope Valves System Changzhou Endoclean Medical Device Co., Ltd., CN | ODC |
| Nov 22, 2023 | K222499 | Disposable Endoscope Valves Kit Shanghai SeeGen Photoelectric Technology Co., Ltd., CN | ODC |
| Oct 20, 2023 | K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biops Steris | ODC |
| Oct 16, 2023 | K232118 | ANDORATE® Valve Kit Ga Health Company Limited, CN | ODC |
| Jan 17, 2023 | K220884 | Disposable Endoscope Valve Sets Sml Med-Tech Solutions Limited, CN | ODC |
| Nov 21, 2022 | K222980 | Pentax Medical Valve Set Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | ODC |
| Sep 8, 2022 | K221331 | Disposable Endoscope Valves System Changzhou Endoclean Medical Device Co., Ltd., CN | ODC |
| Jun 17, 2022 | K220210 | Disposable Endoscopy Adapter Set Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | ODC |
| Jun 1, 2022 | K221264 | FROG Forceps Valve (VAL1-F1-100) Fujifilm Medwork GmbH, DE | ODC |
| Apr 26, 2022 | K213483 | SnapLoc Wire Lock Wilson Cook Medical | ODC |
| Mar 29, 2022 | K220247 | Guidewire Locking Device Micro-Tech (Nanjing) Co., Ltd., CN | ODC |
| Jan 14, 2022 | K211814 | Wellead Endoscopic Seal Well Lead Medical Co., Ltd., CN | ODC |
| Jan 12, 2022 | K213095 | andorate Suction Valve, andorate Air/Water Valve Ga Health Company Limited, CN | ODC |
| Sep 10, 2021 | K210625 | JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve Fujifilm Medwork GmbH, DE | ODC |
| Sep 3, 2021 | K210342 | BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor STERIS Corporation | ODC |
| May 6, 2021 | K210353 | AutoCap RX Boston Scientific Corporation | ODC |
| Jan 14, 2021 | K202104 | BioGuard EUS Air/Water and Suction Valves STERIS Corporation | ODC |
| Jan 8, 2021 | K203630 | BioGuard Air/Water and Suction Valves Steris Corporations | ODC |
| Jan 6, 2021 | K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Wilson Instruments (Sha) Co., Ltd., CN | ODC |
| Dec 23, 2020 | K202237 | Locking device Hangzhou AGS MedTech Co., Ltd., CN | ODC |
| Jun 24, 2020 | K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve Ga Health Company Limited, CN | ODC |
| Jun 18, 2020 | K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator Ga Health Company Limited, CN | ODC |
| May 14, 2020 | K192048 | Single Use Endoscope Valves Set Anrei Medical (Hangzhou) Co., Ltd., CN | ODC |
| Dec 30, 2019 | K192258 | Disposable Valve Sets Zhejiang Chuangxiang Medical Technology Co., Ltd., CN | ODC |
| Sep 17, 2019 | K192059 | Bio Guard Air/Water & Suction Valves United States Endoscopy Group, Inc. | ODC |
| Jun 7, 2019 | K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set Smartdata Suzhou Co., Ltd., CN | ODC |
| Apr 4, 2019 | K190164 | CleverLock Guidewire Locking Device and Biopsy Cap Olympus Surgical Technologies America | ODC |
| Jul 26, 2018 | K181712 | San Antonio Stopcock Cook Incorporated | ODC |
| Mar 22, 2018 | K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter Cook Incorporated | ODC |
| Apr 27, 2017 | K162142 | Accessory Irrigation Adapter Wilson-Cook Medical, Inc. | ODC |
| May 19, 2016 | K160403 | SmartStart Air/Water and Suction Valves Endochoice, Inc. | ODC |
| Dec 3, 2015 | K151714 | Disposable Endoscope Valves Set A Wilson Instruments (Shanghai) Company Limited, CN | ODC |
| Aug 25, 2015 | K151345 | BioGuard Air/Water Valve, BioGuard Suction Valve United States Endoscopy Group, Inc. | ODC |
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