FDA product code EYA: Stylet, Ureteral
EYA is the FDA product code for stylet, ureteral. It is a Class I device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. Devices under EYA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Stylet, Ureteral |
| 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 EYA devices
openFDA lists no recalls for product code EYA.
Frequently asked questions
What is FDA product code EYA?
EYA is the FDA product code for stylet, ureteral. It is a Class I device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is EYA?
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 EYA
- Run a recall and safety report across every EYA manufacturer
- Watch product code EYA 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times