FDA product code OXL: Mesh, Surgical, Absorbable, Organ Support
OXL is the FDA product code for mesh, surgical, absorbable, organ support. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. Devices under OXL 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 organ support.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Absorbable, Organ Support |
| 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 OXL devices
openFDA lists no recalls for product code OXL.
Frequently asked questions
What is FDA product code OXL?
OXL is the FDA product code for mesh, surgical, absorbable, organ support. 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 OXL?
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 OXL
- Run a recall and safety report across every OXL manufacturer
- Watch product code OXL 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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