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.
FDA 510(k) Cleared Duodenoscope And Accessories, Flexible/rigid Devices (Product Code FDT)
About Product Code FDT - Regulatory Context
510(k) Submission Activity
35 total 510(k) submissions under product code FDT since 1983, with 35 receiving FDA clearance (average review time: 147 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for FDT submissions have been consistent, averaging 155 days recently vs 146 days historically.
FDT devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →