FDA product code NNP: Die, Wire Bending, Ent, Non-Sterile
NNP is the FDA product code for die, wire bending, 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 NNP 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 JXW.
Classification
| Field | Value |
|---|---|
| Device name | Die, Wire Bending, 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 NNP devices
openFDA lists no recalls for product code NNP.
Frequently asked questions
What is FDA product code NNP?
NNP is the FDA product code for die, wire bending, 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 NNP?
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 NNP
- Run a recall and safety report across every NNP manufacturer
- Watch product code NNP 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.
All Ear, Nose and Throat product codes · FDA product code lookup