FDA product code NMT: Needle, Catheter, Reprocessed
NMT is the FDA product code for needle, catheter, reprocessed. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. Devices under NMT 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, Catheter, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| 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 NMT devices
openFDA lists no recalls for product code NMT.
Frequently asked questions
What is FDA product code NMT?
NMT is the FDA product code for needle, catheter, reprocessed. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is NMT?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NMT
- Run a recall and safety report across every NMT manufacturer
- Watch product code NMT 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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