FDA product code FWE: Camera, Television, Microsurgical, With Audio
FWE is the FDA product code for camera, television, 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 FWE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for FWE devices.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Television, 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 FWE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-29.
Frequently asked questions
What is FDA product code FWE?
FWE is the FDA product code for camera, television, 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 FWE?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
Have FWE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-02-29.
Next steps
- Run an FDA pathway report with predicate devices for product code FWE
- Run a recall and safety report across every FWE manufacturer
- Watch product code FWE 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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