FDA product code NJZ: Extractor, Vein
NJZ is the FDA product code for extractor, vein. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under NJZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
The device is a vein extractor that is pushed through the leg around the vein to effect saphenous vein harvesting. It is like a long apple corer, but instead of taking out the apple core you are taking our someone's saphenous vein.
Classification
| Field | Value |
|---|---|
| Device name | Extractor, Vein |
| 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) exempt |
Recalls for NJZ devices
openFDA lists no recalls for product code NJZ.
Frequently asked questions
What is FDA product code NJZ?
NJZ is the FDA product code for extractor, vein. 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 NJZ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NJZ
- Run a recall and safety report across every NJZ manufacturer
- Watch product code NJZ 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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