FDA product code NMR: Needle, Spinal, Short Term, Reprocessed
NMR is the FDA product code for needle, spinal, short term, reprocessed. It is a Class II device, regulated under 21 CFR 868.5150 and reviewed by the Anesthesiology panel. Devices under NMR 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, Spinal, Short Term, 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 NMR devices
openFDA lists no recalls for product code NMR.
Frequently asked questions
What is FDA product code NMR?
NMR is the FDA product code for needle, spinal, short term, reprocessed. It is a Class II device, regulated under 21 CFR 868.5150 and reviewed by the Anesthesiology panel.
What device class is NMR?
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 NMR
- Run a recall and safety report across every NMR manufacturer
- Watch product code NMR 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.