Home / 510(k) Clearances / K253211

510(k) K253211

AQUABEAM Robotic System by Procept Biorobotics — Product Code PZP

K253211 is an FDA 510(k) premarket notification submitted by Procept Biorobotics for the device "AQUABEAM Robotic System". The FDA issued a decision of Substantially Equivalent on June 23, 2026. 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
June 23, 2026
Date Received
September 29, 2025
Clearance Type
Traditional
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 (July 9, 2026)
  • 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)

Other clearances for product code PZP

  • K260723 — HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU10 (July 9, 2026)
  • 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)
  • K212835 — AquaBeam Robotic System (October 6, 2021)
  • K202961 — AquaBeam Robotic System (March 11, 2021)
  • DEN170024 — AQUABEAM System (December 21, 2017)

FDA data resources