FDA product code JXW: Die, Wire Bending, Ent, Sterile
JXW is the FDA product code for die, wire bending, 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 JXW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Die, Wire Bending, 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 JXW devices
openFDA lists no recalls for product code JXW.
Frequently asked questions
What is FDA product code JXW?
JXW is the FDA product code for die, wire bending, 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 JXW?
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 JXW
- Run a recall and safety report across every JXW manufacturer
- Watch product code JXW 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times