FDA product code FSZ: Light, Surgical, Carrier
FSZ is the FDA product code for light, surgical, carrier. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. Devices under FSZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Light, Surgical, Carrier |
| 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 FSZ devices
openFDA lists no recalls for product code FSZ.
Frequently asked questions
What is FDA product code FSZ?
FSZ is the FDA product code for light, surgical, carrier. 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 FSZ?
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 FSZ
- Run a recall and safety report across every FSZ manufacturer
- Watch product code FSZ 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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