HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)— 510(k) K260723

Name: FDA 510(k) clearance K260723
Creator: U.S. Food and Drug Administration
Published: 2026-07-09

Substantially Equivalent

Procept Biorobotics

FDA 510(k) clearance K260723 for HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000), Substantially Equivalent on 2026-07-09. Applicant: Procept Biorobotics. Device class: 2.

Clearance details

Device name as filed: HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)
Applicant: Procept Biorobotics
Product code: Code PZP
Device class: Class 2
Regulation: 21 CFR 876.4350
Advisory panel: General, Plastic Surgery
Date received: 2026-03-05
Decision date: 2026-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PZP

view all

K253211 — AQUABEAM Robotic System2026-06-23
K251082 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)2025-10-10
K241952 — AQUABEAM Robotic System (AB2000)2024-09-30
K240200 — HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece2024-08-20
K231024 — AquaBeam Robotic System2023-08-30

Adverse events under product code PZP

product code PZP

Death: 28
Injury: 622
Malfunction: 627
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.