FDA Product Code FDT: Duodenoscope And Accessories, Flexible/rigid
Duodenoscopy is essential for the diagnosis and treatment of pancreaticobiliary disorders. FDA product code FDT covers flexible and rigid duodenoscopes and their accessories.
These side-viewing endoscopes provide access to the ampulla of Vater and the common bile duct for endoscopic retrograde cholangiopancreatography (ERCP), sphincterotomy, and stone extraction. Their elevator mechanism and side-viewing optics are unique among gastrointestinal endoscopes.
FDT devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Olympus Medical Systems Corp., Pentax of America, Inc. and Ambu A/S.
List of Duodenoscope And Accessories, Flexible/rigid devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Duodenoscope And Accessories, Flexible/rigid devices (product code FDT). 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 →