FDA product code OXN: Mesh, Surgical, Collagen, Fistula
OXN is the FDA product code for mesh, surgical, collagen, fistula. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under OXN. The average 510(k) review took 185 days (median 185).
Definition
For reinforcement of soft tissue where weakness exists during the repair of fistulas.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Collagen, Fistula |
| 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 |
510(k) clearances per year for OXN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 185 |
Compare with all 510(k) review times · Search every OXN clearance
Top OXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Biotech Incorporated | 1 | 2019-12-27 |
Most recent OXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191696 | Cook Biotech Incorporated | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft | 2019-12-27 | 185 |
Recalls for OXN devices
openFDA lists no recalls for product code OXN.
Frequently asked questions
What is FDA product code OXN?
OXN is the FDA product code for mesh, surgical, collagen, fistula. 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 OXN?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXN?
Across 1 cleared submissions the average was 185 days from receipt to decision (median 185).
Which companies have the most OXN clearances?
Cook Biotech Incorporated (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OXN
- Run a recall and safety report across every OXN manufacturer
- Watch product code OXN 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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