FDA product code LHY: Electrode, Stabilized Epidural Spinal
LHY is the FDA product code for electrode, stabilized epidural spinal. It is a Class III device, reviewed by the Neurology panel. Devices under LHY reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Stabilized Epidural Spinal |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LHY devices
openFDA lists no recalls for product code LHY.
Frequently asked questions
What is FDA product code LHY?
LHY is the FDA product code for electrode, stabilized epidural spinal. It is a Class III device, reviewed by the Neurology panel.
What device class is LHY?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LHY
- Run a recall and safety report across every LHY manufacturer
- Watch product code LHY 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