510(k) DEN220047
- Device
- Galen ES Cooperative Surgical Assistant Platform, Galen ES
- Applicant
- Galen Robotics
- 510(k) number
- DEN220047
- Product code
- QXG
- Decision
- Unknown (DENG)
- Decision date
- 2023-07-19
- Date received
- 2022-07-22
- Regulation
- 874.4460
- Classification name
- Cooperative Powered Surgical Assist Device For Ent Surgery
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Robert Lawery
- Address
- 1100 Wicomico St., Suite 725 Baltimore MD US 21230 21230
Source Documents
510(k) summary PDF not indicated by FDA