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