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