FDA product code NNU: Scissors, Wire Cutting, Ent, Non-Sterile
NNU is the FDA product code for scissors, wire cutting, ent, non-sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel. Devices under NNU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Prosthesis modification instrument for ossicular replacement surgery; see product code JYA.
Classification
| Field | Value |
|---|---|
| Device name | Scissors, Wire Cutting, Ent, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 874.3540 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NNU devices
openFDA lists no recalls for product code NNU.
Frequently asked questions
What is FDA product code NNU?
NNU is the FDA product code for scissors, wire cutting, ent, non-sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel.
What device class is NNU?
Class I, regulation 21 CFR 874.3540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NNU
- Run a recall and safety report across every NNU manufacturer
- Watch product code NNU 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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