FDA Product Code
FDA Product Code OXH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | 2025-07-15 | Special | PDF ↗ |
| K202430 | Kerecis Reconstruct | Kerecis Limited | 2021-05-02 | Traditional | PDF ↗ |
| K171357 | SurgiMend PRS Meshed, Revize-X | Integra Lifesciences Corporation (Owner of Tei Biosciences) | 2017-06-07 | Special | PDF ↗ |
| K160400 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2016-06-08 | Special | PDF ↗ |
| K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | 2015-05-12 | Traditional | PDF ↗ |
Product code OXH · Class II · General, Plastic Surgery. Data: openFDA.