FDA product code JXX: Forceps, Wire Closure, Ent, Sterile
JXX is the FDA product code for forceps, wire closure, 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 JXX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Wire Closure, 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 JXX devices
openFDA lists no recalls for product code JXX.
Frequently asked questions
What is FDA product code JXX?
JXX is the FDA product code for forceps, wire closure, 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 JXX?
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 JXX
- Run a recall and safety report across every JXX manufacturer
- Watch product code JXX 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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