510(k) K231024
- Device
- AquaBeam Robotic System
- Applicant
- Procept Biorobotics, Corporation
- 510(k) number
- K231024
- Product code
- PZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-30
- Date received
- 2023-04-11
- Regulation
- 876.4350
- Classification name
- Fluid Jet Removal System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sara Muddell
- Address
- 900 Island Dr. Suite 101 Redwood City CA US 94065 94065
FDA Registration Numbers#
- 1222616
- 1225984
- 2246552
- 2030624
- 1047843
- 3043534483
- 3027788423
- 3013944123
Source Documents#
Other 510(k) Records For Product Code PZP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | Procept Biorobotics | 2025-10-10 |
| K241952 | AQUABEAM Robotic System (AB2000) | Procept Biorobotics | 2024-09-30 |
| K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Procept Biorobotics | 2024-08-20 |
| K212835 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021-10-06 |
| K202961 | AquaBeam Robotic System | Procept Biorobotics, Corporation | 2021-03-11 |
| DEN170024 | AQUABEAM System | Procept Biorobotics, Corporation | 2017-12-21 |