ODCClass II

Endoscope Channel Accessory

21 CFR 876.1500 / Gastroenterology, Urology

ODC is the FDA product code for Endoscope Channel Accessory, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To give the endoscope channel additional or improved functionality". As of 2026-09-10, FDA records hold 72 510(k) clearances under this code, the most recent dated 2026-06-12, and 3 recalls.

Classification record

Product code: ODC
Device name: Endoscope Channel Accessory
FDA definition: To give the endoscope channel additional or improved functionality.
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 72
Ingested recalls: 3

Clearances, product code ODC

By decision year

72 clearances under product code ODC with a decision year between 1980 and 2026, 2022 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code ODC by decision year
Year	Clearances
1980	1
1986	1
1989	1
1992	2
1997	1
2001	1
2003	1
2008	3
2009	1
2010	4
2011	4
2012	2
2015	2
2016	1
2017	1
2018	2
2019	4
2020	4
2021	6
2022	8
2023	7
2024	8
2025	6
2026	1

Applicants with the most clearances

Product code ODC

Applicants holding the most 510(k) clearances under product code ODC
Applicant	Clearances
STERIS Corporation	7
Boston Scientific Corporation	4
GA Health Company Limited	4
Byrne Medical, Inc.	3
Medivators (A Subsidiary of Steris Corporation)	3
Smart Medical Systems Ltd.	3
United States Endoscopy Group, Inc.	3
Yangzhou Fartley Medical Instrument Technology Co., Ltd	3
Changzhou Endoclean Medical Device Co., Ltd.	2
Cook Incorporated	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 62 companies shown, in name order