FDA product code FJJ: Dialyzer, Twin Coil
FJJ is the FDA product code for dialyzer, twin coil. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. Devices under FJJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Dialyzer, Twin Coil |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for FJJ devices
openFDA lists no recalls for product code FJJ.
Frequently asked questions
What is FDA product code FJJ?
FJJ is the FDA product code for dialyzer, twin coil. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJJ?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FJJ
- Run a recall and safety report across every FJJ manufacturer
- Watch product code FJJ 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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