FDA product code NEJ: System, Cryosurgical, Liquid Nitrogen, For Gastroenterology
NEJ is the FDA product code for system, cryosurgical, liquid nitrogen, for gastroenterology. It is a Class II device, regulated under 21 CFR 878.4350 and reviewed by the Gastroenterology and Urology panel. Devices under NEJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Cryosurgical, Liquid Nitrogen, For Gastroenterology |
| Device class | Class II |
| Regulation | 21 CFR 878.4350 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for NEJ devices
openFDA lists no recalls for product code NEJ.
Frequently asked questions
What is FDA product code NEJ?
NEJ is the FDA product code for system, cryosurgical, liquid nitrogen, for gastroenterology. It is a Class II device, regulated under 21 CFR 878.4350 and reviewed by the Gastroenterology and Urology panel.
What device class is NEJ?
Class II, regulation 21 CFR 878.4350. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NEJ
- Run a recall and safety report across every NEJ manufacturer
- Watch product code NEJ 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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