21 CFR 874.4460 — Cooperative Powered Surgical Assist Device For Ent Surgery
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4460
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QXG | Cooperative Powered Surgical Assist Device For Ent Surgery | 2 | 1 | SaMD |
Special Controls
QXG — Cooperative Powered Surgical Assist Device For Ent Surgery
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:
De Novo Order DEN220047
