AquaBeam Robotic System
FDA 510(k) clearance K212835 · decided 2021-10-06
Clearance details
- K-number
- K212835
- Device name
- AquaBeam Robotic System
- Applicant
- Procept Biorobotics, Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-09-07
- Decision date
- 2021-10-06
- Days to decision
- 29 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Procept Biorobotics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K202961) | Procept Biorobotics, Corporation | 2021-03-11 |
| AQUABEAM System (DEN170024) | Procept Biorobotics, Corporation | 2017-12-21 |
Recalls involving this device
No recalls on record reference this clearance.