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, Actuated Medical, Inc. and Ambu A/S.
FDA 510(k) Cleared Colonoscope And Accessories, Flexible/rigid Devices (Product Code FDF)
About Product Code FDF - Regulatory Context
510(k) Submission Activity
111 total 510(k) submissions under product code FDF since 1976, with 111 receiving FDA clearance (average review time: 131 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 8 in the prior period.
FDA Review Time
Recent submissions under FDF have taken an average of 164 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
FDF devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →