FDA product code LYI: Stimulator, Subcortical, Implanted For Epilepsy
LYI is the FDA product code for stimulator, subcortical, implanted for epilepsy. It is a Class III device, reviewed by the Neurology panel. Devices under LYI reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Subcortical, Implanted For Epilepsy |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for LYI devices
openFDA lists no recalls for product code LYI.
Frequently asked questions
What is FDA product code LYI?
LYI is the FDA product code for stimulator, subcortical, implanted for epilepsy. It is a Class III device, reviewed by the Neurology panel.
What device class is LYI?
Class III. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code LYI
- Run a recall and safety report across every LYI manufacturer
- Watch product code LYI 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times