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.