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 Medivators (A Subsidiary of Steris Corporation).
FDA 510(k) Cleared Endoscope Channel Accessory Devices (Product Code ODC)
About Product Code ODC - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code ODC since 1980, with 71 receiving FDA clearance (average review time: 128 days).
Submission volume has declined in recent years - 9 submissions in the last 24 months compared to 16 in the prior period.
FDA Review Time
FDA review times for ODC submissions have been consistent, averaging 114 days recently vs 130 days historically.
ODC devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →