FDA Product Code FDI: Snare, Flexible
Leading manufacturers include STERIS Corporation, Hangzhou AGS MedTech Co., Ltd. and Micro-Tech (Nanjing) Co., Ltd..
FDA 510(k) Cleared Snare, Flexible Devices (Product Code FDI)
About Product Code FDI - Regulatory Context
510(k) Submission Activity
63 total 510(k) submissions under product code FDI since 1985, with 63 receiving FDA clearance (average review time: 121 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under FDI have taken an average of 264 days to reach a decision - up from 119 days historically. Manufacturers should account for longer review timelines in current project planning.
FDI devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →