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510(k) DEN170024

AQUABEAM System by Procept Biorobotics, Corporation — Product Code PZP

DEN170024 is an FDA 510(k) premarket notification submitted by Procept Biorobotics, Corporation for the device "AQUABEAM System". The FDA issued a decision of De Novo Granted on Dec 21, 2017. The device falls under product code PZP (Fluid Jet Removal System), a Class II device regulated under 21 CFR 876.4350. Procept Biorobotics, Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
Dec 21, 2017
Date Received
Apr 17, 2017
Clearance Type
Direct
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 by Procept Biorobotics, Corporation

  • K231024 — AquaBeam Robotic System (Aug 30, 2023)
  • K212835 — AquaBeam Robotic System (Oct 6, 2021)
  • K202961 — AquaBeam Robotic System (Mar 11, 2021)

Other clearances for product code PZP

  • K260723 — HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU10 (Jul 9, 2026)
  • K253211 — AQUABEAM Robotic System (Jun 23, 2026)
  • K251082 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU (Oct 10, 2025)
  • K241952 — AQUABEAM Robotic System (AB2000) (Sep 30, 2024)
  • K240200 — HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (Aug 20, 2024)
  • K231024 — AquaBeam Robotic System (Aug 30, 2023)
  • K212835 — AquaBeam Robotic System (Oct 6, 2021)
  • K202961 — AquaBeam Robotic System (Mar 11, 2021)

FDA data resources