Product code PZP— General, Plastic Surgery
AquaBeam Robotic System
- Classification name
- Fluid Jet Removal System
- Device class
- Class 2
- Regulation
- 21 CFR 876.4350
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“The system is used for removal of prostate tissue with a fluid jet.”
Market context for product code PZP
FDA has cleared devices under product code PZP between 2017 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2024
- 2023
- 2021
- 2017
Top applicants under product code PZP
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 →
Recent clearances under product code PZP
- 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
- K231024 — AquaBeam Robotic System
- K212835 — AquaBeam Robotic System
- K202961 — AquaBeam Robotic System
- DEN170024 — AQUABEAM System
Data sourced from openFDA. This site is unofficial and independent of the FDA.