FDA product code MFE: Agent, Injectable, Embolic
MFE is the FDA product code for agent, injectable, embolic. It is a Class III device, reviewed by the Neurology panel. Devices under MFE reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 2 recalls for MFE devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Agent, Injectable, Embolic |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MFE devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-01-11.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code MFE?
MFE is the FDA product code for agent, injectable, embolic. It is a Class III device, reviewed by the Neurology panel.
What device class is MFE?
Class III. Typical premarket route: PMA.
Have MFE devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2024-01-11.
Next steps
- Run an FDA pathway report with predicate devices for product code MFE
- Run a recall and safety report across every MFE manufacturer
- Watch product code MFE 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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