FDA product code HXE: Fork
HXE is the FDA product code for fork. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. Devices under HXE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fork |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Recalls for HXE devices
openFDA lists no recalls for product code HXE.
Frequently asked questions
What is FDA product code HXE?
HXE is the FDA product code for fork. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXE?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HXE
- Run a recall and safety report across every HXE manufacturer
- Watch product code HXE 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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