AquaBeam Robotic System— 510(k) K231024
Substantially EquivalentProcept Biorobotics, Corporation
FDA 510(k) clearance K231024 for AquaBeam Robotic System, Substantially Equivalent on 2023-08-30. Applicant: Procept Biorobotics, Corporation. Device class: 2.
Clearance details
- Applicant
- Procept Biorobotics, Corporation
- Product code
- 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
- Redwood City, CA, US
Recent devices under product code PZP
view all- K260723 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
- K253211 — AQUABEAM Robotic System
- 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
More clearances from Procept Biorobotics, Corporation
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.