FDA product code FXT: Film, Camera, Surgical
FXT is the FDA product code for film, camera, surgical. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel. Devices under FXT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Film, Camera, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4160 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for FXT devices
openFDA lists no recalls for product code FXT.
Frequently asked questions
What is FDA product code FXT?
FXT is the FDA product code for film, camera, surgical. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel.
What device class is FXT?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FXT
- Run a recall and safety report across every FXT manufacturer
- Watch product code FXT 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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