PZP
9 FDA 510(k) clearances · Product code
162 daysmedian time to decision
267 days90th percentile
9clearances measured
FDA profile
- Official device name
- Fluid Jet Removal System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4350
- Medical specialty
- General, Plastic Surgery
- FDA definition
- The system is used for removal of prostate tissue with a fluid jet.
- Adverse events (MAUDE)
- 2021: 99 · 2022: 174 · 2023: 254 · 2024: 309 · 2025: 291 · 2026: 153
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) (K260723) | Procept Biorobotics | 2026-07-09 |
| AQUABEAM Robotic System (K253211) | Procept Biorobotics | 2026-06-23 |
| HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (K251082) | Procept Biorobotics | 2025-10-10 |
| AQUABEAM Robotic System (AB2000) (K241952) | Procept Biorobotics | 2024-09-30 |
| HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (K240200) | Procept Biorobotics | 2024-08-20 |
| AquaBeam Robotic System (K231024) | Procept Biorobotics, Corporation | 2023-08-30 |
| AquaBeam Robotic System (K212835) | Procept Biorobotics, Corporation | 2021-10-06 |
| AquaBeam Robotic System (K202961) | Procept Biorobotics, Corporation | 2021-03-11 |
| AQUABEAM System (DEN170024) | Procept Biorobotics, Corporation | 2017-12-21 |
Track PZP automatically
Every clearance here is in the API, with alerts when new ones post.