FDA product code MSA: Dressing, Wound And Burn, Occlusive, Heated
MSA is the FDA product code for dressing, wound and burn, occlusive, heated. It is a Class I device, regulated under 21 CFR 878.4020 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under MSA. The average 510(k) review took 120 days (median 120).
Classification
| Field | Value |
|---|---|
| Device name | Dressing, Wound And Burn, Occlusive, Heated |
| Device class | Class I |
| Regulation | 21 CFR 878.4020 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MSA clearance
Top MSA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Augustine Medical, Inc. | 2 | 2002-01-31 |
Most recent MSA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020077 | Augustine Medical, Inc. | MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX | 2002-01-31 | 22 |
| K963293 | Augustine Medical, Inc. | AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX | 1997-03-28 | 219 |
Recalls for MSA devices
openFDA lists no recalls for product code MSA.
Frequently asked questions
What is FDA product code MSA?
MSA is the FDA product code for dressing, wound and burn, occlusive, heated. It is a Class I device, regulated under 21 CFR 878.4020 and reviewed by the General and Plastic Surgery panel.
What device class is MSA?
Class I, regulation 21 CFR 878.4020. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSA?
Across 2 cleared submissions the average was 120 days from receipt to decision (median 120).
Which companies have the most MSA clearances?
Augustine Medical, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MSA
- Run a recall and safety report across every MSA manufacturer
- Watch product code MSA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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