FDA product code OXF: Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
OXF is the FDA product code for mesh, surgical, absorbable, plastic and reconstructive surgery. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under OXF, 4 in the last five years, from 6 different applicants. The average 510(k) review took 139 days (median 125); 204 days on average over the last three years.
Definition
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| 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 OXF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 58 |
| 2018 | 1 | 164 |
| 2022 | 1 | 84 |
| 2024 | 1 | 269 |
| 2025 | 2 | 138 |
Compare with all 510(k) review times · Search every OXF clearance
Top OXF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Printbio, Inc. | 2 | 2025-05-21 |
| W. L. Gore & Associates, Inc. | 2 | 2018-04-05 |
| Acera Surgical, Inc. | 1 | 2025-06-20 |
| W. L. Gore and Associates, Inc. | 1 | 2022-12-19 |
| Sofregen Medical, Inc. | 1 | 2017-09-22 |
1 more applicants have OXF clearances. See the full list in Caduvo.
Most recent OXF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251224 | Acera Surgical, Inc. | Restrata Soft Tissue Reinforcement (STR) | 2025-06-20 | 60 |
| K243302 | Printbio, Inc. | 3DMatrix DynaFlex (DynaFlex) | 2025-05-21 | 215 |
| K232602 | Printbio, Inc. | 3DMatrix Surgical Mesh | 2024-05-23 | 269 |
| K222919 | W. L. Gore and Associates, Inc. | GORE® ENFORM Biomaterial | 2022-12-19 | 84 |
| K173333 | W. L. Gore & Associates, Inc. | GORE ENFORM Biomaterial | 2018-04-05 | 164 |
Recalls for OXF devices
openFDA lists no recalls for product code OXF.
Frequently asked questions
What is FDA product code OXF?
OXF is the FDA product code for mesh, surgical, absorbable, plastic and reconstructive surgery. 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 OXF?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXF?
Across 8 cleared submissions the average was 139 days from receipt to decision (median 125).
Which companies have the most OXF clearances?
Printbio, Inc. (2); W. L. Gore & Associates, Inc. (2); Acera Surgical, Inc. (1); W. L. Gore and Associates, Inc. (1); Sofregen Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OXF
- Run a recall and safety report across every OXF manufacturer
- Watch product code OXF 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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