OXJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
- 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 in abdominal wall defects.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Avance Abdominal Dressing Kit (K161939) | Molnlycke Health Care Us, LLC | 2016-11-17 |
| AVANCE® FOAM ABDOMINAL DRESSING KIT (K130852) | Molnlycke Health Care | 2014-04-14 |
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Every clearance here is in the API, with alerts when new ones post.