FDA product code GXT: Monitor, Lesion Temperature
GXT is the FDA product code for monitor, lesion temperature. It is a Class II device, regulated under 21 CFR 882.5500 and reviewed by the Neurology panel. Devices under GXT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Lesion Temperature |
| Device class | Class II |
| Regulation | 21 CFR 882.5500 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for GXT devices
openFDA lists no recalls for product code GXT.
Frequently asked questions
What is FDA product code GXT?
GXT is the FDA product code for monitor, lesion temperature. It is a Class II device, regulated under 21 CFR 882.5500 and reviewed by the Neurology panel.
What device class is GXT?
Class II, regulation 21 CFR 882.5500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GXT
- Run a recall and safety report across every GXT manufacturer
- Watch product code GXT 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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