PZP

Fluid Jet Removal System

Product code: PZP
Device name: Fluid Jet Removal System
Device class: Class 2
21 CFR: 21 CFR 876.4350
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 5
Summaries archived here: 3 (direct download)
510(k) clearances (all years, FDA): 9 (all years; only the last 3 years are listed here)

FDA classification definition

The system is used for removal of prostate tissue with a fluid jet.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Last three years. Most recent: 2026-07-09.

Number	Decision date	Applicant	Device name	Summary
K260723	2026-07-09	Procept Biorobotics	HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1	PDF
K253211	2026-06-23	Procept Biorobotics	AQUABEAM Robotic System	PDF
K251082	2025-10-10	Procept Biorobotics	HYDROS Robotic System (HY1000); HYDROS Handpiece (HH	PDF
K241952	2024-09-30	Procept Biorobotics	AQUABEAM Robotic System (AB2000)	FDA
K240200	2024-08-20	Procept Biorobotics	HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Han	FDA

3 summaries are archived here for direct download.

Official FDA classification page: PZP

Classification and pathway per current FDA publications. Data from openFDA (CC0).