K251082
- 510(k) number
- K251082
- 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
- 2025-10-10
- Date received
- 2025-04-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K251082.pdf
Official FDA record: K251082
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.