OXC
- Product code
- OXC
- Device name
- Mesh, Surgical, Absorbable, 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)
- 9
FDA classification definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252906 | 2026-01-09 | Ethicon Endo-Surgery, LLC | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | |
| K231603 | 2023-10-06 | Standard Bariatrics, Inc. | Standard Staple-Line Reinforcement (SSLR23) |
Official FDA classification page: OXC
Classification and pathway per current FDA publications. Data from openFDA (CC0).