FDA product code NMY: Needle, Endoscopic, Reprocessed
NMY is the FDA product code for needle, endoscopic, reprocessed. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under NMY 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, Endoscopic, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for NMY devices
openFDA lists no recalls for product code NMY.
Frequently asked questions
What is FDA product code NMY?
NMY is the FDA product code for needle, endoscopic, reprocessed. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is NMY?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NMY
- Run a recall and safety report across every NMY manufacturer
- Watch product code NMY 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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