QXG — Cooperative Powered Surgical Assist Device For Ent Surgery Class II
FDA product code QXG covers "Cooperative Powered Surgical Assist Device For Ent Surgery", a Class II medical device regulated under 21 CFR 874.4460. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXG
- Device Class
- Class II
- Regulation Number
- 874.4460
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220047 | galen robotics | Galen ES Cooperative Surgical Assistant Platform, Galen ES | July 19, 2023 |