FDA product code NNN: Crimper, Wire, Ent, Non-Sterile
NNN is the FDA product code for crimper, wire, 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 NNN 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 JXT.
Classification
| Field | Value |
|---|---|
| Device name | Crimper, Wire, 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 NNN devices
openFDA lists no recalls for product code NNN.
Frequently asked questions
What is FDA product code NNN?
NNN is the FDA product code for crimper, wire, 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 NNN?
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 NNN
- Run a recall and safety report across every NNN manufacturer
- Watch product code NNN 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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