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