AquaBeam Robotic System AB2000
by PROCEPT BioRobotics Corporation
AquaBeam Robotic System AB2000 is a Class II device made by PROCEPT BioRobotics Corporation, granted FDA De Novo DEN170024 on 21 Dec 2017 and listed in FDA GUDID since 28 Mar 2019 (UDI-DI B614AB20001), active as of 23 Oct 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB614AB20001 | Date28 Mar 2019 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN170024 | Date21 Dec 2017 | StatusActive |
Official records
- FDA De Novo database DEN170024
Across registries
- FDA De Novo DEN170024 decided 21 Dec 2017 Active
- FDA GUDID UDI-DI B614AB20001 listed 28 Mar 2019 Listed
Timeline
- Granted FDA De Novo DEN170024
- Listed FDA GUDID B614AB20001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- AquaBeam Robotic System
- Generic name
- Water jet knife system
- Model / Ref / Catalog
- AB2000
- Primary DI / UDI-DI
- B614AB20001
- De Novo Number
- FDA product code
- PZP
- GMDN term
- Water jet knife system
- Device class
- Class II
- Regulation number
- 876.4350
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe