FDA product code GXJ: Punch, Skull
GXJ is the FDA product code for punch, skull. It is a Class I device, regulated under 21 CFR 882.4750 and reviewed by the Neurology panel. Devices under GXJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Punch, Skull |
| Device class | Class I |
| Regulation | 21 CFR 882.4750 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for GXJ devices
openFDA lists no recalls for product code GXJ.
Frequently asked questions
What is FDA product code GXJ?
GXJ is the FDA product code for punch, skull. It is a Class I device, regulated under 21 CFR 882.4750 and reviewed by the Neurology panel.
What device class is GXJ?
Class I, regulation 21 CFR 882.4750. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GXJ
- Run a recall and safety report across every GXJ manufacturer
- Watch product code GXJ 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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