FDA product code FJN: Stabilizer, Shunt
FJN is the FDA product code for stabilizer, shunt. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. Devices under FJN reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Stabilizer, Shunt |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for FJN devices
openFDA lists no recalls for product code FJN.
Frequently asked questions
What is FDA product code FJN?
FJN is the FDA product code for stabilizer, shunt. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is FJN?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FJN
- Run a recall and safety report across every FJN manufacturer
- Watch product code FJN 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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