FDA Product Code PZP: Fluid Jet Removal System
The System Is Used For Removal Of Prostate Tissue With A Fluid Jet.
Leading manufacturers include Procept Biorobotics, Corporation and Procept Biorobotics.
FDA 510(k) Cleared Fluid Jet Removal System Devices (Product Code PZP)
About Product Code PZP - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code PZP since 2017, with 6 receiving FDA clearance (average review time: 152 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for PZP submissions have been consistent, averaging 160 days recently vs 145 days historically.
PZP devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →