FDA product code NNH: Needle, Conduction, Anesthesia, Reprocessed
NNH is the FDA product code for needle, conduction, anesthesia, reprocessed. It is a Class II device, regulated under 21 CFR 868.5150 and reviewed by the Anesthesiology panel. Devices under NNH reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A reprocessed needle is a device used to inject local anesthesia into a patient to provide regional anesthesia. This is the same as "BSP." 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, Conduction, Anesthesia, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 868.5150 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NNH devices
openFDA lists no recalls for product code NNH.
Frequently asked questions
What is FDA product code NNH?
NNH is the FDA product code for needle, conduction, anesthesia, reprocessed. It is a Class II device, regulated under 21 CFR 868.5150 and reviewed by the Anesthesiology panel.
What device class is NNH?
Class II, regulation 21 CFR 868.5150. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NNH
- Run a recall and safety report across every NNH manufacturer
- Watch product code NNH 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.