FDA Product Code PIF: Gastrointestinal Tubes With Enteral Specific Connectors
To Facilitate Enteral Specific Connections.
Leading manufacturers include Hmc Premedical S.P.A., SKY Medical, a.s. and Degania Silicone , Ltd..
FDA 510(k) Cleared Gastrointestinal Tubes With Enteral Specific Connectors Devices (Product Code PIF)
About Product Code PIF - Regulatory Context
510(k) Submission Activity
50 total 510(k) submissions under product code PIF since 2014, with 50 receiving FDA clearance (average review time: 169 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 8 in the prior period.
FDA Review Time
FDA review times for PIF submissions have been consistent, averaging 147 days recently vs 170 days historically.
PIF devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →