FDA product code GZE: Implanted Diaphragmatic/Phrenic Nerve Stimulator
GZE is the FDA product code for implanted diaphragmatic/phrenic nerve stimulator. It is a Class III device, regulated under 21 CFR 882.5830 and reviewed by the Anesthesiology panel. Devices under GZE reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86
Classification
| Field | Value |
|---|---|
| Device name | Implanted Diaphragmatic/Phrenic Nerve Stimulator |
| Device class | Class III |
| Regulation | 21 CFR 882.5830 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Neurology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for GZE devices
openFDA lists no recalls for product code GZE.
Frequently asked questions
What is FDA product code GZE?
GZE is the FDA product code for implanted diaphragmatic/phrenic nerve stimulator. It is a Class III device, regulated under 21 CFR 882.5830 and reviewed by the Anesthesiology panel.
What device class is GZE?
Class III, regulation 21 CFR 882.5830. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code GZE
- Run a recall and safety report across every GZE manufacturer
- Watch product code GZE 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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