FDA product code NNX: Device, Incontinence, Urosheath Type, Non-Sterile
NNX is the FDA product code for device, incontinence, urosheath type, non-sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. Devices under NNX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Urine collector and accessories; see product code EXJ
Classification
| Field | Value |
|---|---|
| Device name | Device, Incontinence, Urosheath Type, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NNX devices
openFDA lists no recalls for product code NNX.
Frequently asked questions
What is FDA product code NNX?
NNX is the FDA product code for device, incontinence, urosheath type, non-sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is NNX?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NNX
- Run a recall and safety report across every NNX manufacturer
- Watch product code NNX 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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