OWV
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mesh, Surgical, Collagen, Diaphragmatic Hernia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.
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| Record | Firm | Date |
|---|---|---|
| DIAPHRAGMATIC HERNIA GRAFT (K133011) | Cook Biotech, Inc. | 2014-06-20 |
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Every clearance here is in the API, with alerts when new ones post.