FDA product code GXC: Device, Electroconvulsive Therapy
GXC is the FDA product code for device, electroconvulsive therapy. It is a Class III device, regulated under 21 CFR 882.5940 and reviewed by the Neurology panel. Devices under GXC reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Electroconvulsive Therapy |
| Device class | Class III |
| Regulation | 21 CFR 882.5940 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | PMA |
Recalls for GXC devices
openFDA lists no recalls for product code GXC.
Frequently asked questions
What is FDA product code GXC?
GXC is the FDA product code for device, electroconvulsive therapy. It is a Class III device, regulated under 21 CFR 882.5940 and reviewed by the Neurology panel.
What device class is GXC?
Class III, regulation 21 CFR 882.5940. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code GXC
- Run a recall and safety report across every GXC manufacturer
- Watch product code GXC 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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