FDA product code FXZ: Helmet, Surgical
FXZ is the FDA product code for helmet, surgical. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. Devices under FXZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Helmet, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for FXZ devices
openFDA lists no recalls for product code FXZ.
Frequently asked questions
What is FDA product code FXZ?
FXZ is the FDA product code for helmet, surgical. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is FXZ?
Class I, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FXZ
- Run a recall and safety report across every FXZ manufacturer
- Watch product code FXZ 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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