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510(k) K251082

Device
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
Applicant
Procept Biorobotics
510(k) number
K251082
Product code
PZP
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-10
Date received
2025-04-09
Regulation
876.4350
Classification name
Fluid Jet Removal System
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Bijesh Chandran
Address
150 Baytech Dr. San Jose CA US 95134 95134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241952AQUABEAM Robotic System (AB2000)Procept Biorobotics2024-09-30
K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics2024-08-20
K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation2023-08-30
K212835AquaBeam Robotic SystemProcept Biorobotics, Corporation2021-10-06
K202961AquaBeam Robotic SystemProcept Biorobotics, Corporation2021-03-11
DEN170024AQUABEAM SystemProcept Biorobotics, Corporation2017-12-21