FDA product code NMU: Needle, Gastro-Urology, Reprocessed
NMU is the FDA product code for needle, gastro-urology, reprocessed. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under NMU 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, Gastro-Urology, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NMU devices
openFDA lists no recalls for product code NMU.
Frequently asked questions
What is FDA product code NMU?
NMU is the FDA product code for needle, gastro-urology, reprocessed. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is NMU?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NMU
- Run a recall and safety report across every NMU manufacturer
- Watch product code NMU 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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