QXG · Cooperative Powered Surgical Assist Device For Ent Surgery
Ear, Nose, Throat · 21 CFR 874.4460 · Class 2
Overview
| Product Code | QXG |
|---|---|
| Device Name | Cooperative Powered Surgical Assist Device For Ent Surgery |
| Regulation | 21 CFR 874.4460 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
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 surgeon's direct physical control of the instrument. The Galen ES is intended to assist in the movement of the specified Integra Jako Micro Laryngeal Alligator Forceps to a surgeon-selected position within a surgical field and remain in place until moved elsewhere by the operator.
Classification Rationale
Class II (special controls). The device is granted under the De Novo process as a cooperative powered surgical assist device for ENT surgery (21 CFR 874.4460).
Special Controls
In combination with the general controls of the FD&C Act, the cooperative powered surgical assist device for ENT surgery is subject to the following special controls:
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220047 | Galen ES Cooperative Surgical Assistant Platform, Galen ES | Galen Robotics | Jul 19, 2023 | DENG |
Top Applicants
- Galen Robotics — 1 clearance
