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.
8
Total
7
Cleared
166d
Avg days
2017
Since
Growing category -
4 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
187d
recently vs 145d historically
FDA 510(k) Cleared Fluid Jet Removal System Devices (Product Code PZP)
8 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
8 total 510(k) submissions under product code PZP since 2017, with 7 receiving FDA clearance (average review time: 166 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PZP Product Code
Recent submissions under PZP have taken an average of 187 days to reach a decision - up from 145 days historically. Manufacturers should account for longer review timelines in current project planning.
PZP devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →