FDA product code JXT: Crimper, Wire, Ent, Sterile
JXT is the FDA product code for crimper, wire, ent, sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel. Devices under JXT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Crimper, Wire, Ent, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 874.3540 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for JXT devices
openFDA lists no recalls for product code JXT.
Frequently asked questions
What is FDA product code JXT?
JXT is the FDA product code for crimper, wire, ent, sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel.
What device class is JXT?
Class I, regulation 21 CFR 874.3540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JXT
- Run a recall and safety report across every JXT manufacturer
- Watch product code JXT 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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