FDA product code NJE: Intracranial Neurovascular Stent
NJE is the FDA product code for intracranial neurovascular stent. It is a HDE device, reviewed by the Neurology panel. Devices under NJE reach the market by Unclassified; FDA lists no cleared 510(k)s for it. FDA has posted 7 recalls for NJE devices.
Definition
An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use.
Classification
| Field | Value |
|---|---|
| Device name | Intracranial Neurovascular Stent |
| Device class | HDE |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for NJE devices
7 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code NJE?
NJE is the FDA product code for intracranial neurovascular stent. It is a HDE device, reviewed by the Neurology panel.
What device class is NJE?
HDE. Typical premarket route: Unclassified.
Have NJE devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2018-06-05.
Next steps
- Run an FDA pathway report with predicate devices for product code NJE
- Run a recall and safety report across every NJE manufacturer
- Watch product code NJE 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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