K240200
- 510(k) number
- K240200
- Device name
- HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
- Applicant
- Procept Biorobotics CA · US
- Product code
- PZP — Fluid Jet Removal System
- Decision date
- 2024-08-20
- Date received
- 2024-01-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K240200.pdf
Official FDA record: K240200
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.