OXE
- Product code
- OXE
- Device name
- Mesh, Surgical, Collagen, Staple Line Reinforcement
- 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)
- 4
FDA classification definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Official FDA classification page: OXE
Classification and pathway per current FDA publications. Data from openFDA (CC0).