FDA Product Code FIE: Needle, Fistula
Leading manufacturers include JMS North America Corporation.
FDA 510(k) Cleared Needle, Fistula Devices (Product Code FIE)
About Product Code FIE - Regulatory Context
510(k) Submission Activity
79 total 510(k) submissions under product code FIE since 1977, with 79 receiving FDA clearance (average review time: 120 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FIE have taken an average of 58 days to reach a decision - down from 121 days historically, suggesting improved FDA processing for this classification.
FIE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →