FDA product code FSX: Light, Surgical, Connector
FSX is the FDA product code for light, surgical, connector. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. Devices under FSX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Light, Surgical, Connector |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for FSX devices
openFDA lists no recalls for product code FSX.
Frequently asked questions
What is FDA product code FSX?
FSX is the FDA product code for light, surgical, connector. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is FSX?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FSX
- Run a recall and safety report across every FSX manufacturer
- Watch product code FSX 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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