Skip to contentDe Novo DEN220047
- Device
- Galen ES Cooperative Surgical Assistant Platform, Galen ES
- Contact
- robert lawery
- De Novo number
- DEN220047
- Product code
- QXG
- Regulation
- 874.4460
- Classification name
- cooperative powered surgical assist device for ent surgery
- Decision
- granted (DENG)
- Decision date
- 2023-07-19
- Date received
- 2022-07-22
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Direct
Current FDA Classification#
- Product code
- QXG
- Device name
- Cooperative Powered Surgical Assist Device For Ent Surgery
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.4460
- Implant
- N
- Life sustain/support
- N