MSA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dressing, Wound And Burn, Occlusive, Heated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2000: 11 · 2001: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (K020077) | Augustine Medical, Inc. | 2002-01-31 |
| AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (K963293) | Augustine Medical, Inc. | 1997-03-28 |
Track MSA automatically
Every clearance here is in the API, with alerts when new ones post.