Redwood City, CA, US · 8 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PZP | Fluid Jet Removal System | Class II | General, Plastic Surgery | 8 | 2026-07-09 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-07-09 | Class II | Ongoing | Z-2330-2021 | AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System. | — | Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachm… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-09 | K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | PZP | Class II | General, Plastic Surgery |
| 2026-06-23 | K253211 | AQUABEAM Robotic System | PZP | Class II | General, Plastic Surgery |
| 2025-10-10 | K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | PZP | Class II | General, Plastic Surgery |
| 2024-09-30 | K241952 | AQUABEAM Robotic System (AB2000) | PZP | Class II | General, Plastic Surgery |
| 2024-08-20 | K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | PZP | Class II | General, Plastic Surgery |
| 2023-08-30 | K231024 | AquaBeam Robotic System | PZP | Class II | General, Plastic Surgery |
| 2021-10-06 | K212835 | AquaBeam Robotic System | PZP | Class II | General, Plastic Surgery |
| 2021-03-11 | K202961 | AquaBeam Robotic System | PZP | Class II | General, Plastic Surgery |