Home / 510(k) Clearances / K241952

510(k) K241952

AQUABEAM Robotic System (AB2000) by Procept Biorobotics — Product Code PZP

K241952 is an FDA 510(k) premarket notification submitted by Procept Biorobotics for the device "AQUABEAM Robotic System (AB2000)". The FDA issued a decision of Substantially Equivalent on Sep 30, 2024. The device falls under product code PZP (Fluid Jet Removal System), a Class II device regulated under 21 CFR 876.4350. Procept Biorobotics has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 30, 2024
Date Received
Jul 3, 2024
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 by Procept Biorobotics

  • 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)
  • K240200 — HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (Aug 20, 2024)

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)
  • 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)
  • DEN170024 — AQUABEAM System (Dec 21, 2017)

FDA data resources