FDA product code NNE: Needle, Fistula, Reprocessed
NNE is the FDA product code for needle, fistula, reprocessed. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. Devices under NNE 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, Fistula, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for NNE devices
openFDA lists no recalls for product code NNE.
Frequently asked questions
What is FDA product code NNE?
NNE is the FDA product code for needle, fistula, reprocessed. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is NNE?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NNE
- Run a recall and safety report across every NNE manufacturer
- Watch product code NNE 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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