HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) is an AI-enabled medical device from Procept Biorobotics, listed by FDA (510(k), K251082) with a decision date of 2025-10-10. Review panel: General and Plastic Surgery.
| FDA submission number | K251082 |
|---|---|
| Pathway | 510(k) |
| Company | Procept Biorobotics |
| Review panel (specialty) | General and Plastic Surgery |
| FDA decision date | 2025-10-10 |
| Decision | Substantially Equivalent |
| Product code | PZP |
| Classification | Fluid Jet Removal System |
| Device class | 2 |
| Regulation number | 876.4350 |
| Review time (calendar days) | 184 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All General and Plastic Surgery AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.