FDA product code HNE: Snare, Enucleating
HNE is the FDA product code for snare, enucleating. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. Devices under HNE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Snare, Enucleating |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HNE devices
openFDA lists no recalls for product code HNE.
Frequently asked questions
What is FDA product code HNE?
HNE is the FDA product code for snare, enucleating. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNE?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HNE
- Run a recall and safety report across every HNE manufacturer
- Watch product code HNE 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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