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