FDA product code NNC: Needle, Aspiration And Needle, Reprocessed
NNC is the FDA product code for needle, aspiration and needle, reprocessed. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under NNC 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, Aspiration And Needle, 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 NNC devices
openFDA lists no recalls for product code NNC.
Frequently asked questions
What is FDA product code NNC?
NNC is the FDA product code for needle, aspiration and needle, 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 NNC?
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 NNC
- Run a recall and safety report across every NNC manufacturer
- Watch product code NNC 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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