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