Galen ES Cooperative Surgical Assistant Platform, Galen ES
FDA 510(k) clearance DEN220047 · decided 2023-07-19
Clearance details
- K-number
- DEN220047
- Device name
- Galen ES Cooperative Surgical Assistant Platform, Galen ES
- Applicant
- Galen Robotics
- Decision
- Unknown
- Date received
- 2022-07-22
- Decision date
- 2023-07-19
- Days to decision
- 362 days
- Clearance type
- Direct
- Product code
- QXG
- Device class
- 2
- Regulation number
- 874.4460
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Baltimore, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.