FDA product code HEF: Binder, Breast
HEF is the FDA product code for binder, breast. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel. Devices under HEF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Binder, Breast |
| Device class | Class I |
| Regulation | 21 CFR 880.5160 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HEF devices
openFDA lists no recalls for product code HEF.
Frequently asked questions
What is FDA product code HEF?
HEF is the FDA product code for binder, breast. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel.
What device class is HEF?
Class I, regulation 21 CFR 880.5160. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HEF
- Run a recall and safety report across every HEF manufacturer
- Watch product code HEF 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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