AQUABEAM Robotic System— 510(k) K253211
Substantially EquivalentProcept Biorobotics
FDA 510(k) clearance K253211 for AQUABEAM Robotic System, Substantially Equivalent on 2026-06-23. Applicant: Procept Biorobotics. Device class: 2.
Summary
Procept Biorobotics' AQUABEAM Robotic System is filed under PZP, fluid jet removal systems. The record doesn't say which procedures or components the clearance covers.
Class II, 21 CFR 876.4350. The Gastroenterology and Urology review panel handled it as a Traditional 510(k); the record lists General and Plastic Surgery as the classification panel.
Procept filed from San Jose, California. The decision came 267 calendar days after FDA received it (September 29, 2025 to June 23, 2026).
Clearance details
- 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 all- K260723 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
- K251082 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
- K241952 — AQUABEAM Robotic System (AB2000)
- K240200 — HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
- K231024 — AquaBeam Robotic System
Adverse 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.