FDA product code QXG

Cooperative Powered Surgical Assist Device For Ent Surgery

Ear, Nose, Throat·Class 2·21 CFR 874.4460
US regulatory classifications
US Product Code (FDA)
QXG
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 874.4460
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Medical specialty
Ear, Nose, Throat
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Cooperative Powered Surgical Assist Device For Ent Surgery is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.