510(k) DEN220047
DEN220047 is an FDA 510(k) premarket notification submitted by Galen Robotics for the device "Galen ES Cooperative Surgical Assistant Platform, Galen ES". The FDA issued a decision of De Novo Granted on July 19, 2023. The device falls under product code QXG (Cooperative Powered Surgical Assist Device For Ent Surgery), a Class II device regulated under 21 CFR 874.4460.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 19, 2023
- Date Received
- July 22, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cooperative Powered Surgical Assist Device For Ent Surgery
- Device Class
- Class II
- Regulation Number
- 874.4460
- Review Panel
- EN
- Submission Type
A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeons direct physical control of the instrument.