OXN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mesh, Surgical, Collagen, Fistula
- 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 the repair of fistulas.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft (K191696) | Cook Biotech Incorporated | 2019-12-27 | + Add |
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