FDA product code NCK: Button, Iris, Eye, Artificial
NCK is the FDA product code for button, iris, eye, artificial. It is a Class I device, regulated under 21 CFR 886.3200 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NCK. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Button, Iris, Eye, Artificial |
| Device class | Class I |
| Regulation | 21 CFR 886.3200 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NCK clearance
Top NCK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ocular Concepts, LLC | 1 | 2000-06-13 |
Most recent NCK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001326 | Ocular Concepts, LLC | NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON | 2000-06-13 | 48 |
Recalls for NCK devices
openFDA lists no recalls for product code NCK.
Frequently asked questions
What is FDA product code NCK?
NCK is the FDA product code for button, iris, eye, artificial. It is a Class I device, regulated under 21 CFR 886.3200 and reviewed by the Ophthalmic panel.
What device class is NCK?
Class I, regulation 21 CFR 886.3200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NCK?
Across 1 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most NCK clearances?
Ocular Concepts, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NCK
- Run a recall and safety report across every NCK manufacturer
- Watch product code NCK 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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