PZP — Fluid Jet Removal System Class II
FDA product code PZP covers "Fluid Jet Removal System", a Class II medical device regulated under 21 CFR 876.4350. Submissions are reviewed by the General, Plastic Surgery panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PZP
- Device Class
- Class II
- Regulation Number
- 876.4350
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
The system is used for removal of prostate tissue with a fluid jet.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260723 | Procept Biorobotics | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU10 | Jul 9, 2026 |
| K253211 | Procept Biorobotics | AQUABEAM Robotic System | Jun 23, 2026 |
| K251082 | Procept Biorobotics | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU | Oct 10, 2025 |
| K241952 | Procept Biorobotics | AQUABEAM Robotic System (AB2000) | Sep 30, 2024 |
| K240200 | Procept Biorobotics | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Aug 20, 2024 |
| K231024 | Procept Biorobotics, Corporation | AquaBeam Robotic System | Aug 30, 2023 |
| K212835 | Procept Biorobotics, Corporation | AquaBeam Robotic System | Oct 6, 2021 |
| K202961 | Procept Biorobotics, Corporation | AquaBeam Robotic System | Mar 11, 2021 |
| DEN170024 | Procept Biorobotics, Corporation | AQUABEAM System | Dec 21, 2017 |