FDA product code LYJ: Stimulator, Autonomic Nerve, Implanted For Epilepsy
LYJ is the FDA product code for stimulator, autonomic nerve, implanted for epilepsy. It is a Class III device, reviewed by the Neurology panel. Devices under LYJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 37 recalls for LYJ devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LYJ devices
37 product recalls in 28 recall events; 5 initiated in the last five years and 7 still open. Most recent: 2025-01-03.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 5 |
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 1 |
| 2024 | 2 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LYJ?
LYJ is the FDA product code for stimulator, autonomic nerve, implanted for epilepsy. It is a Class III device, reviewed by the Neurology panel.
What device class is LYJ?
Class III. Typical premarket route: PMA.
Have LYJ devices been recalled?
Yes: 37 product recalls across 28 recall events; the most recent began 2025-01-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LYJ
- Run a recall and safety report across every LYJ manufacturer
- Watch product code LYJ 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