FDA product code EXM: Truss, Umbilical
EXM is the FDA product code for truss, umbilical. It is a Class I device, regulated under 21 CFR 876.5970 and reviewed by the General and Plastic Surgery panel. Devices under EXM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Truss, Umbilical |
| Device class | Class I |
| Regulation | 21 CFR 876.5970 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for EXM devices
openFDA lists no recalls for product code EXM.
Frequently asked questions
What is FDA product code EXM?
EXM is the FDA product code for truss, umbilical. It is a Class I device, regulated under 21 CFR 876.5970 and reviewed by the General and Plastic Surgery panel.
What device class is EXM?
Class I, regulation 21 CFR 876.5970. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EXM
- Run a recall and safety report across every EXM manufacturer
- Watch product code EXM 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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