FDA product code FWI: Camera, Cine, Surgical, With Audio
FWI is the FDA product code for camera, cine, surgical, with audio. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel. Devices under FWI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Cine, Surgical, With Audio |
| 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 FWI devices
openFDA lists no recalls for product code FWI.
Frequently asked questions
What is FDA product code FWI?
FWI is the FDA product code for camera, cine, surgical, with audio. 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 FWI?
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 FWI
- Run a recall and safety report across every FWI manufacturer
- Watch product code FWI 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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