QXG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cooperative Powered Surgical Assist Device For Ent Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4460
- Medical specialty
- Ear, Nose, Throat
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Galen ES Cooperative Surgical Assistant Platform, Galen ES (DEN220047) | Galen Robotics | 2023-07-19 |
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Every clearance here is in the API, with alerts when new ones post.