FDA product code NZK: Stimulator, Low Electric Field, Tumor Treatment
NZK is the FDA product code for stimulator, low electric field, tumor treatment. It is a Class III device, reviewed by the Neurology panel. Devices under NZK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Low Electric Field, Tumor Treatment |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for NZK devices
openFDA lists no recalls for product code NZK.
Frequently asked questions
What is FDA product code NZK?
NZK is the FDA product code for stimulator, low electric field, tumor treatment. It is a Class III device, reviewed by the Neurology panel.
What device class is NZK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NZK
- Run a recall and safety report across every NZK manufacturer
- Watch product code NZK 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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