← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
ODC — Endoscope Channel Accessory
To give the endoscope channel additional or improved functionality.
DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
10
510(K)/PMA CLEARANCES
510k: 10
0
RECALL ENTRIES
Recent clearances
K252933Dyne Medical Group, Inc. · 510k2026-06-12
K250145Endosound, Inc. · 510k2025-10-17
K252910Boston Scientific · 510k2025-10-09
K250949Olympus Medical Systems Corporation · 510k2025-07-16
K250732Yangzhou Fartley Medical Instrument Technology Co., Ltd. · 510k2025-06-20
K241842Olympus Medical Systems Corporation · 510k2025-03-19
K250140Steris Corparation · 510k2025-02-20
K243075STERIS Corporation · 510k2024-11-08
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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