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