FDA product code OXI: Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
OXI is the FDA product code for mesh, surgical, absorbable, large abdominal wall defects. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. Devices under OXI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
For reinforcement of soft tissue where weakness exists in abdominal wall defects.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Absorbable, Large Abdominal Wall Defects |
| 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 OXI devices
openFDA lists no recalls for product code OXI.
Frequently asked questions
What is FDA product code OXI?
OXI is the FDA product code for mesh, surgical, absorbable, large abdominal wall defects. 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 OXI?
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 OXI
- Run a recall and safety report across every OXI manufacturer
- Watch product code OXI 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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