FDA Product Code FDF: Colonoscope And Accessories, Flexible/rigid

Colonoscopy is the gold standard for colorectal cancer screening and polyp removal. FDA product code FDF covers flexible and rigid colonoscopes and their accessories.

These long endoscopes allow gastroenterologists to visualize and perform procedures throughout the entire colon and terminal ileum. They are used for colorectal cancer screening, polyp removal, biopsy of inflammatory bowel disease, and treatment of gastrointestinal bleeding.

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

Leading manufacturers include Pentax Precision Instrument Corp., Motus GI Medical Technologies , Ltd. and Lumendi, LLC.