K260723

HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)

510(k) number
K260723
Device name
HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)
Applicant
Procept Biorobotics CA · US
Product code
PZP — Fluid Jet Removal System
Decision date
2026-07-09
Date received
2026-03-05
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K260723.pdf

Official FDA record: K260723
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.