OXH
- Product code
- OXH
- Device name
- Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 5
FDA classification definition
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251844 | 2025-07-15 | Kerecis Limited | Kerecis SurgiBind (50241) |
Official FDA classification page: OXH
Classification and pathway per current FDA publications. Data from openFDA (CC0).