FDA product code NNO: Jig, Piston Cutting, Ent, Non-Sterile
NNO is the FDA product code for jig, piston 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 NNO 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 JXY.
Classification
| Field | Value |
|---|---|
| Device name | Jig, Piston 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 NNO devices
openFDA lists no recalls for product code NNO.
Frequently asked questions
What is FDA product code NNO?
NNO is the FDA product code for jig, piston 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 NNO?
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 NNO
- Run a recall and safety report across every NNO manufacturer
- Watch product code NNO 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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