FDA product code FJA: Manometer, Water
FJA is the FDA product code for manometer, water. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. Devices under FJA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Manometer, Water |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for FJA devices
openFDA lists no recalls for product code FJA.
Frequently asked questions
What is FDA product code FJA?
FJA is the FDA product code for manometer, water. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJA?
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 FJA
- Run a recall and safety report across every FJA manufacturer
- Watch product code FJA 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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