Clearance Summary
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) received FDA 510(k) clearance under submission number K251082, sponsored by Procept Biorobotics. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2025-10-10.
- Submission: K251082
- Applicant / Sponsor: Procept Biorobotics
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 876.4350
- Decision date: 2025-10-10
Classification & Regulation
This clearance is catalogued under FDA product code PZP and 21 CFR 876.4350, within the General, Plastic Surgery review panel as a Class II device.