FDA product code FXE: Speculum, Non-Illuminated
FXE is the FDA product code for speculum, non-illuminated. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel. Devices under FXE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Speculum, Non-Illuminated |
| Device class | Class I |
| Regulation | 21 CFR 878.1800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for FXE devices
openFDA lists no recalls for product code FXE.
Frequently asked questions
What is FDA product code FXE?
FXE is the FDA product code for speculum, non-illuminated. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel.
What device class is FXE?
Class I, regulation 21 CFR 878.1800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FXE
- Run a recall and safety report across every FXE manufacturer
- Watch product code FXE 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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