OXN — Mesh, Surgical, Collagen, Fistula Class II
Classification Details
- Product Code
- OXN
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For reinforcement of soft tissue where weakness exists during the repair of fistulas.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191696 | cook biotech incorporated | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery M | December 27, 2019 |