ODC · Class II · 21 CFR 876.1500

FDA Product Code ODC: Endoscope Channel Accessory

FDA product code ODC covers endoscope channel accessories that enhance or expand the functional capabilities of endoscope working channels.

These accessories include channel extenders, overtubes, capping devices, and other add-ons that improve access, provide additional suction or irrigation, or enable procedures not possible with the standard endoscope configuration.

ODC devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include STERIS Corporation, Olympus Medical Systems Corporation and Boston Scientific Corporation.

13
Total
13
Cleared
93d
Avg days
2021
Since

List of Endoscope Channel Accessory devices cleared through 510(k)

13 devices
1–13 of 13
Cleared Oct 09, 2025
Orca Air/Water and Suction Valves
K252910
Boston Scientific
Gastroenterology & Urology · 27d
Cleared Jul 16, 2025
Suction Valve (MAJ-1443)
K250949
Olympus Medical Systems Corporation
Gastroenterology & Urology · 110d
Cleared Mar 19, 2025
Luer-Split MAJ-2092
K241842
Olympus Medical Systems Corporation
Gastroenterology & Urology · 266d
Cleared Nov 08, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
K243075
STERIS Corporation
Gastroenterology & Urology · 42d
Cleared Oct 11, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K242742
STERIS Corporation
Gastroenterology & Urology · 30d
Cleared Mar 06, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes
K240352
STERIS Corporation
Gastroenterology & Urology · 30d
Cleared Feb 09, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K240098
STERIS Corporation
Gastroenterology & Urology · 28d
Cleared Dec 01, 2023
PENTAX Medical Gas/Water Feeding Valve OE-B14
K232249
Pentax of America, Inc.
Gastroenterology & Urology · 126d
Cleared Oct 20, 2023
BioShield Biopsy Valve (00711124)
K232951
Steris
Gastroenterology & Urology · 29d
Cleared Mar 29, 2022
Guidewire Locking Device
K220247
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 60d
Cleared Sep 03, 2021
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
K210342
STERIS Corporation
Gastroenterology & Urology · 210d
Cleared May 06, 2021
AutoCap RX
K210353
Boston Scientific Corporation
Gastroenterology & Urology · 87d
Cleared Jan 14, 2021
BioGuard EUS Air/Water and Suction Valves
K202104
STERIS Corporation
Gastroenterology & Urology · 169d

How to use this database

This page lists all FDA 510(k) submissions for Endoscope Channel Accessory devices (product code ODC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →