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510(k) K251082

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) by Procept Biorobotics — Product Code PZP

K251082 is an FDA 510(k) premarket notification submitted by Procept Biorobotics for the device "HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)". The FDA issued a decision of Substantially Equivalent on Oct 10, 2025. 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
Oct 10, 2025
Date Received
Apr 9, 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 (Jul 9, 2026)
  • K253211 — AQUABEAM Robotic System (Jun 23, 2026)
  • K241952 — AQUABEAM Robotic System (AB2000) (Sep 30, 2024)
  • 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)
  • 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)
  • DEN170024 — AQUABEAM System (Dec 21, 2017)

FDA data resources