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510(k) K202961

Device
AquaBeam Robotic System
Applicant
PROCEPT BioRobotics Corporation
510(k) number
K202961
Product code
PZP  
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-11
Date received
2020-09-30
Regulation
876.4350
Classification name
Fluid Jet Removal System
Medical specialty
General & Plastic Surgery
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sara Muddell
Address
900 Island Dr. Suite 101 Redwood City CA US 94065 94065

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
K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)Procept Biorobotics2025-10-10
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
DEN170024AQUABEAM SystemProcept Biorobotics, Corporation2017-12-21

Legacy Summary#

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FDA Review#

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