FDA product code QGX: General Use Pneumatic Tourniquet
QGX is the FDA product code for general use pneumatic tourniquet. It is a Class I device, regulated under 21 CFR 878.5910 and reviewed by the General and Plastic Surgery panel. Devices under QGX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation.
Classification
| Field | Value |
|---|---|
| Device name | General Use Pneumatic Tourniquet |
| Device class | Class I |
| Regulation | 21 CFR 878.5910 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for QGX devices
openFDA lists no recalls for product code QGX.
Frequently asked questions
What is FDA product code QGX?
QGX is the FDA product code for general use pneumatic tourniquet. It is a Class I device, regulated under 21 CFR 878.5910 and reviewed by the General and Plastic Surgery panel.
What device class is QGX?
Class I, regulation 21 CFR 878.5910. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QGX
- Run a recall and safety report across every QGX manufacturer
- Watch product code QGX 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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