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510(k) K212835

AquaBeam Robotic System by Procept Biorobotics, Corporation — Product Code PZP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 6, 2021
Date Received: September 7, 2021
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Fluid Jet Removal System
Device Class: Class II
Regulation Number: 876.4350
Review Panel: GU
Submission Type

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

Other clearances for product code PZP

K251082 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU (October 10, 2025)
K241952 — AQUABEAM Robotic System (AB2000) (September 30, 2024)
K240200 — HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (August 20, 2024)
K231024 — AquaBeam Robotic System (August 30, 2023)
K202961 — AquaBeam Robotic System (March 11, 2021)
DEN170024 — AQUABEAM System (December 21, 2017)