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