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, Ga Health Company Limited and Yangzhou Fartley Medical Instrument Technology Co., Ltd..