AQUABEAM System
FDA 510(k) clearance DEN170024 · decided 2017-12-21
Clearance details
- K-number
- DEN170024
- Device name
- AQUABEAM System
- Applicant
- Procept Biorobotics, Corporation
- Decision
- Unknown
- Date received
- 2017-04-17
- Decision date
- 2017-12-21
- Days to decision
- 248 days
- Clearance type
- Direct
- Product code
- PZP
- Device class
- 2
- Regulation number
- 876.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) (K260723) | Procept Biorobotics | 2026-07-09 |
| AQUABEAM Robotic System (K253211) | Procept Biorobotics | 2026-06-23 |
| HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (K251082) | Procept Biorobotics | 2025-10-10 |
| AQUABEAM Robotic System (AB2000) (K241952) | Procept Biorobotics | 2024-09-30 |
| HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (K240200) | Procept Biorobotics | 2024-08-20 |
| AquaBeam Robotic System (K231024) | Procept Biorobotics, Corporation | 2023-08-30 |
| AquaBeam Robotic System (K212835) | Procept Biorobotics, Corporation | 2021-10-06 |
| AquaBeam Robotic System (K202961) | Procept Biorobotics, Corporation | 2021-03-11 |
Recalls involving this device
No recalls on record reference this clearance.