Part 876 Subpart E—Surgical Devices
FDA submissions for Part 876 Subpart E—Surgical Devices in the General, Plastic Surgery (SU) review panel, including product codes, regulations, and recent device decisions.
Section range: § 876.4350
CFR Part: 876
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| PZP | Fluid Jet Removal System | 876.4350 | 2 | 7 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | Procept Biorobotics | Oct 10, 2025 |
| K241952 | AQUABEAM Robotic System (AB2000) | Procept Biorobotics | Sep 30, 2024 |
| K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Procept Biorobotics | Aug 20, 2024 |
| K231024 | AquaBeam Robotic System | Procept Biorobotics, Corporation | Aug 30, 2023 |
| K212835 | AquaBeam Robotic System | Procept Biorobotics, Corporation | Oct 6, 2021 |
| K202961 | AquaBeam Robotic System | Procept Biorobotics, Corporation | Mar 11, 2021 |
| DEN170024 | AQUABEAM System | Procept Biorobotics, Corporation | Dec 21, 2017 |
