FDA product code NKZ: Endoilluminator, Reprocessed
NKZ is the FDA product code for endoilluminator, reprocessed. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Ophthalmic panel. Devices under NKZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Used intraocularly to provide light into the posterior of the eye during retinal surgery. Same as product code MPA, except this one is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Endoilluminator, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for NKZ devices
openFDA lists no recalls for product code NKZ.
Frequently asked questions
What is FDA product code NKZ?
NKZ is the FDA product code for endoilluminator, reprocessed. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Ophthalmic panel.
What device class is NKZ?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NKZ
- Run a recall and safety report across every NKZ manufacturer
- Watch product code NKZ 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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