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 Fujifilm Corporation, Ambu A/S and Pentax of America, Inc..
List of Colonoscope And Accessories, Flexible/rigid devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Colonoscope And Accessories, Flexible/rigid devices (product code FDF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →