FDA product code MCN: Barrier, Absorbable, Adhesion
MCN is the FDA product code for barrier, absorbable, adhesion. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under MCN reach the market by PMA; FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code. FDA has posted 3 recalls for MCN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Barrier, Absorbable, Adhesion |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MCN devices
3 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-03-15.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code MCN?
MCN is the FDA product code for barrier, absorbable, adhesion. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is MCN?
Class III. Typical premarket route: PMA.
Have MCN devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2024-03-15.
Next steps
- Run an FDA pathway report with predicate devices for product code MCN
- Run a recall and safety report across every MCN manufacturer
- Watch product code MCN 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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