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.
9
Total
8
Cleared
162d
Avg days
2017
Since
Growing category -
4 submissions in the last 2 years
vs 2 in the prior period
Consistent review times:
167d avg (recent)
FDA 510(k) Cleared Fluid Jet Removal System Devices (Product Code PZP)
9 devices
Cleared
Oct 10, 2025
HYDROS Robotic System (HY1000)
Procept Biorobotics
Gastroenterology & Urology
184d
Cleared
Sep 30, 2024
AQUABEAM Robotic System (AB2000)
Procept Biorobotics
Gastroenterology & Urology
89d
Cleared
Aug 20, 2024
HYDROS Robotic System
Procept Biorobotics
Gastroenterology & Urology
208d
Cleared
Aug 30, 2023
AquaBeam Robotic System
Procept Biorobotics, Corporation
Gastroenterology & Urology
141d
Cleared
Oct 06, 2021
AquaBeam Robotic System
Procept Biorobotics, Corporation
Gastroenterology & Urology
29d
Cleared
Mar 11, 2021
AquaBeam Robotic System
Procept Biorobotics, Corporation
Gastroenterology & Urology
162d
About Product Code PZP - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PZP since 2017, with 8 receiving FDA clearance (average review time: 162 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PZP Product Code
FDA review times for PZP submissions have been consistent, averaging 167 days recently vs 158 days historically.
PZP devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →