FDA product code FXS: Frame, Camera, Surgical
FXS is the FDA product code for frame, 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 FXS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Frame, 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 FXS devices
openFDA lists no recalls for product code FXS.
Frequently asked questions
What is FDA product code FXS?
FXS is the FDA product code for frame, 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 FXS?
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 FXS
- Run a recall and safety report across every FXS manufacturer
- Watch product code FXS 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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