FDA product code EYJ: Holder, Ureteral Catheter
EYJ is the FDA product code for holder, ureteral catheter. It is a Class I device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. Devices under EYJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Holder, Ureteral Catheter |
| Device class | Class I |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for EYJ devices
openFDA lists no recalls for product code EYJ.
Frequently asked questions
What is FDA product code EYJ?
EYJ is the FDA product code for holder, ureteral catheter. It is a Class I device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is EYJ?
Class I, regulation 21 CFR 876.5130. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EYJ
- Run a recall and safety report across every EYJ manufacturer
- Watch product code EYJ 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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