FDA product code NNB: Needle, Reproduction, Assisted, Reprocessed
NNB is the FDA product code for needle, reproduction, assisted, reprocessed. It is a Class II device, regulated under 21 CFR 884.6100 and reviewed by the Obstetrics and Gynecology panel. Devices under NNB 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, Reproduction, Assisted, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 884.6100 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NNB devices
openFDA lists no recalls for product code NNB.
Frequently asked questions
What is FDA product code NNB?
NNB is the FDA product code for needle, reproduction, assisted, reprocessed. It is a Class II device, regulated under 21 CFR 884.6100 and reviewed by the Obstetrics and Gynecology panel.
What device class is NNB?
Class II, regulation 21 CFR 884.6100. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NNB
- Run a recall and safety report across every NNB manufacturer
- Watch product code NNB 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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