HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)— 510(k) K260723
Substantially EquivalentProcept Biorobotics
FDA 510(k) clearance K260723 for HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000), Substantially Equivalent on 2026-07-09. Applicant: Procept Biorobotics. Device class: 2.
Summary
Procept BioRobotics' clearance covers the HYDROS Robotic System (HY1000), HYDROS Handpiece (HH1000), and HYDROS TRUS Probe (HU1000). They're filed under PZP, fluid jet removal systems, and the record doesn't expand "TRUS".
Class II, 21 CFR 876.4350. The Gastroenterology and Urology review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Procept BioRobotics filed from San Jose, California. Review took 126 calendar days (March 5 to July 9, 2026).
Clearance details
- Device name as filed
- HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)
- Applicant
- Procept Biorobotics
- Product code
- Product code PZP
- Device class
- Class 2
- Regulation
- 21 CFR 876.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code PZP
view allAdverse events under product code PZP
product code PZP- Death
- 28
- Injury
- 622
- Malfunction
- 627
- Total
- 1,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.