FDA product code QXG: Cooperative Powered Surgical Assist Device For Ent Surgery
QXG is the FDA product code for cooperative powered surgical assist device for ent surgery. It is a Class II device, regulated under 21 CFR 874.4460 and reviewed by the Ear, Nose and Throat panel. Devices under QXG reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cooperative Powered Surgical Assist Device For Ent Surgery |
| Device class | Class II |
| Regulation | 21 CFR 874.4460 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Recalls for QXG devices
openFDA lists no recalls for product code QXG.
Frequently asked questions
What is FDA product code QXG?
QXG is the FDA product code for cooperative powered surgical assist device for ent surgery. It is a Class II device, regulated under 21 CFR 874.4460 and reviewed by the Ear, Nose and Throat panel.
What device class is QXG?
Class II, regulation 21 CFR 874.4460. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXG
- Run a recall and safety report across every QXG manufacturer
- Watch product code QXG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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