QXG

Cooperative Powered Surgical Assist Device For Ent Surgery

Product code

QXG

Device name

Cooperative Powered Surgical Assist Device For Ent Surgery

Device class

Class 2

21 CFR

21 CFR 874.4460

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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 surgeon’s direct physical control of the instrument.

Definition text from the FDA device classification database (U.S. federal government work, public domain).