OXE
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mesh, Surgical, Collagen, 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 |
|---|---|---|
| Biodesign Staple Line Reinforcement (K170945) | Cook Biotech Incorporated | 2017-04-28 |
| Kerecis SecureMesh (K153364) | Kerecis Limited | 2016-08-19 |
| VERITAS COLLAGEN MATRIX (K030879) | Synovis Surgical Innovations | 2003-04-24 |
| SURGISIS STAPLE LINE REINFORCEMENT (K022044) | Cook Biotech, Inc. | 2002-08-23 |
Track OXE automatically
Every clearance here is in the API, with alerts when new ones post.