OXD
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K010936) | W. L. Gore & Associates, Inc. | 2001-05-21 |
| SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K001789) | W. L. Gore & Associates, Inc. | 2000-07-06 |
| SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL (K955364) | W. L. Gore & Associates, Inc. | 1996-02-01 |
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