Clearance Summary
Galen ES Cooperative Surgical Assistant Platform, Galen ES received FDA 510(k) clearance under submission number DEN220047, sponsored by Galen Robotics. The device was reviewed via the Direct premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2023-07-19.
- Submission: DEN220047
- Applicant / Sponsor: Galen Robotics
- Clearance pathway: Direct
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4460
- Decision date: 2023-07-19
Classification & Regulation
This clearance is catalogued under FDA product code QXG and 21 CFR 874.4460, within the Ear, Nose, Throat review panel as a Class II device.