PZP · Class II · 21 CFR 876.4350

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 and Procept Biorobotics, Corporation.

9
Total
8
Cleared
162d
Avg days
2017
Since
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg 192d recently vs 146d historically

FDA 510(k) Cleared Fluid Jet Removal System Devices (Product Code PZP)

9 devices
1–9 of 9
Cleared Jul 09, 2026
HYDROS Robotic System (HY1000)
K260723
Procept Biorobotics
Gastroenterology & Urology · 126d
Cleared Jun 23, 2026
AQUABEAM Robotic System
K253211
Procept Biorobotics
Gastroenterology & Urology · 267d
Cleared Oct 10, 2025
HYDROS Robotic System (HY1000)
K251082
Procept Biorobotics
Gastroenterology & Urology · 184d
Cleared Sep 30, 2024
AQUABEAM Robotic System (AB2000)
K241952
Procept Biorobotics
Gastroenterology & Urology · 89d
Cleared Aug 20, 2024
HYDROS Robotic System
K240200
Procept Biorobotics
Gastroenterology & Urology · 208d
Cleared Aug 30, 2023
AquaBeam Robotic System
K231024
Procept Biorobotics, Corporation
Gastroenterology & Urology · 141d
Cleared Oct 06, 2021
AquaBeam Robotic System
K212835
Procept Biorobotics, Corporation
Gastroenterology & Urology · 29d
Cleared Mar 11, 2021
AquaBeam Robotic System
K202961
Procept Biorobotics, Corporation
Gastroenterology & Urology · 162d
Not Cleared Dec 21, 2017
AQUABEAM System
DEN170024
Procept Biorobotics, Corporation
Gastroenterology & Urology · 248d

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 remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - PZP Product Code

Recent submissions under PZP have taken an average of 192 days to reach a decision - up from 146 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 →