FDA Product Code FGE: Stents, Drains And Dilators For The Biliary Ducts
FDA product code FGE covers stents, drains, and dilators for the biliary ducts.
These devices are used endoscopically or percutaneously to restore and maintain patency of the bile duct when obstructed by stones, strictures, or malignancy. Biliary stents are the mainstay of palliative treatment for malignant biliary obstruction and are also used in benign strictures following liver transplant or injury.
FGE devices are Class II medical devices, regulated under 21 CFR 876.5010 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Boston Scientific, Micro-Tech (Nanjing) Co., Ltd. and Cook Ireland, Ltd..
List of Stents, Drains And Dilators For The Biliary Ducts devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Stents, Drains And Dilators For The Biliary Ducts devices (product code FGE). 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 →