FDA product code QGI: Air-Handling Apparatus Accessory
QGI is the FDA product code for air-handling apparatus accessory. It is a Class I device, regulated under 21 CFR 878.5080 and reviewed by the General Hospital panel. Devices under QGI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches.
Classification
| Field | Value |
|---|---|
| Device name | Air-Handling Apparatus Accessory |
| Device class | Class I |
| Regulation | 21 CFR 878.5080 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for QGI devices
openFDA lists no recalls for product code QGI.
Frequently asked questions
What is FDA product code QGI?
QGI is the FDA product code for air-handling apparatus accessory. It is a Class I device, regulated under 21 CFR 878.5080 and reviewed by the General Hospital panel.
What device class is QGI?
Class I, regulation 21 CFR 878.5080. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QGI
- Run a recall and safety report across every QGI manufacturer
- Watch product code QGI 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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