Mesh, Surgical, Collagen, Fistula
The Mesh, Surgical, Collagen, Fistula is a collagen-based surgical mesh implant used for reinforcement of soft tissue where weakness exists during the repair of fistulas. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OXN, with regulation number 878.3300 under the General, Plastic Surgery medical specialty, and it carries an implant flag.
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Basic Information
- Product Code
- OXN
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
For reinforcement of soft tissue where weakness exists during the repair of fistulas.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft | Dec 27, 2019 | Substantially Equivalent | Cook Biotech Incorporated |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.