FDA product code MBX: Stimulator, Thalamic, Epilepsy, Implanted
MBX is the FDA product code for stimulator, thalamic, epilepsy, implanted. It is a Class III device, reviewed by the Neurology panel. Devices under MBX reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Thalamic, Epilepsy, Implanted |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MBX devices
openFDA lists no recalls for product code MBX.
Frequently asked questions
What is FDA product code MBX?
MBX is the FDA product code for stimulator, thalamic, epilepsy, implanted. It is a Class III device, reviewed by the Neurology panel.
What device class is MBX?
Class III. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MBX
- Run a recall and safety report across every MBX manufacturer
- Watch product code MBX 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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