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..
FDA 510(k) Cleared Stents, Drains And Dilators For The Biliary Ducts Devices (Product Code FGE)
About Product Code FGE - Regulatory Context
510(k) Submission Activity
474 total 510(k) submissions under product code FGE since 1982, with 474 receiving FDA clearance (average review time: 127 days).
Submission volume has increased in recent years - 16 submissions in the last 24 months compared to 10 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FGE have taken an average of 194 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.
FGE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →