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