AquaBeam System 210101
by PROCEPT BioRobotics Corporation
AquaBeam System 210101 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 11 Jan 2018 (UDI-DI B6142101011), 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 | NumberB6142101011 | Date11 Jan 2018 | 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 B6142101011 listed 11 Jan 2018 Listed
Timeline
- Granted FDA De Novo DEN170024
- Listed FDA GUDID B6142101011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- AquaBeam System
- Generic name
- Water jet knife system
- Model / Ref / Catalog
- 210101
- Primary DI / UDI-DI
- B6142101011
- 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