FDA product code OXH: Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
OXH is the FDA product code for mesh, surgical, collagen, 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 5 510(k) submissions under OXH, 1 in the last five years, from 3 different applicants. The average 510(k) review took 103 days (median 90); 29 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, Collagen, 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 OXH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 29 |
| 2021 | 1 | 250 |
| 2025 | 1 | 29 |
Compare with all 510(k) review times · Search every OXH clearance
Top OXH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kerecis Limited | 2 | 2025-07-15 |
| Miromatrix Medical, Inc. | 2 | 2016-06-08 |
| Integra Lifesciences Corporation (Owner of Tei Biosciences) | 1 | 2017-06-07 |
Most recent OXH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251844 | Kerecis Limited | Kerecis SurgiBind (50241) | 2025-07-15 | 29 |
| K202430 | Kerecis Limited | Kerecis Reconstruct | 2021-05-02 | 250 |
| K171357 | Integra Lifesciences Corporation (Owner of Tei Biosciences) | SurgiMend PRS Meshed, Revize-X | 2017-06-07 | 29 |
| K160400 | Miromatrix Medical, Inc. | Miromatrix Biological Mesh | 2016-06-08 | 117 |
| K150341 | Miromatrix Medical, Inc. | Miromatrix Biological Mesh RS | 2015-05-12 | 90 |
Recalls for OXH devices
openFDA lists no recalls for product code OXH.
Frequently asked questions
What is FDA product code OXH?
OXH is the FDA product code for mesh, surgical, collagen, 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 OXH?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OXH?
Across 5 cleared submissions the average was 103 days from receipt to decision (median 90).
Which companies have the most OXH clearances?
Kerecis Limited (2); Miromatrix Medical, Inc. (2); Integra Lifesciences Corporation (Owner of Tei Biosciences) (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OXH
- Run a recall and safety report across every OXH manufacturer
- Watch product code OXH 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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