FDA product code OXM: Mesh, Surgical, Absorbable, Fistula
OXM is the FDA product code for mesh, surgical, absorbable, fistula. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. Devices under OXM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
For reinforcement of soft tissue where weakness exists during the repair of fistulas.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Absorbable, Fistula |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for OXM devices
openFDA lists no recalls for product code OXM.
Frequently asked questions
What is FDA product code OXM?
OXM is the FDA product code for mesh, surgical, absorbable, fistula. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is OXM?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OXM
- Run a recall and safety report across every OXM manufacturer
- Watch product code OXM 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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