FDA product code NMX: Needle And Needle Set, Gastro-Urology, Reprocessed
NMX is the FDA product code for needle and needle set, gastro-urology, reprocessed. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel. Devices under NMX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Needle And Needle Set, Gastro-Urology, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.1075 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NMX devices
openFDA lists no recalls for product code NMX.
Frequently asked questions
What is FDA product code NMX?
NMX is the FDA product code for needle and needle set, gastro-urology, reprocessed. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel.
What device class is NMX?
Class II, regulation 21 CFR 876.1075. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NMX
- Run a recall and safety report across every NMX manufacturer
- Watch product code NMX 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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