FDA Product Code
FDA Product Code PZP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 876.4350
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | Procept Biorobotics | 2026-07-09 | Traditional | PDF ↗ |
| K253211 | AQUABEAM Robotic System | Procept Biorobotics | 2026-06-23 | Traditional | PDF ↗ |
| K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | Procept Biorobotics | 2025-10-10 | Traditional | PDF ↗ |
| K241952 | AQUABEAM Robotic System (AB2000) | Procept Biorobotics | 2024-09-30 | Special | PDF ↗ |
| K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Procept Biorobotics | 2024-08-20 | Traditional | PDF ↗ |
| K231024 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2023-08-30 | Traditional | PDF ↗ |
| K212835 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021-10-06 | Special | PDF ↗ |
| K202961 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021-03-11 | Traditional | PDF ↗ |
| DEN170024 | AQUABEAM System | Procept Biorobotics, Corporation | 2017-12-21 | Direct | — |
Product code PZP · Class II · General, Plastic Surgery. Data: openFDA.