Devices · Procept Biorobotics

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

Procept Biorobotics is listed for HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (K251082). The FDA list gives October 10, 2025 as the date of the final decision. The lead panel is General and Plastic Surgery, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PZP as “Fluid Jet Removal System”: The system is used for removal of prostate tissue with a fluid jet. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251082

Official FDA database record

Date of final decision

October 10, 2025

Company on the FDA list

Procept Biorobotics

Lead panel

General and Plastic Surgery

Primary product code

PZP

openFDA device name for the code

Fluid Jet Removal System

Device class

2

Regulation number

876.4350

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary