FDA product code EYS: Ribdam

EYS is the FDA product code for ribdam. It is a Class I device, regulated under 21 CFR 876.4560 and reviewed by the Gastroenterology and Urology panel. Devices under EYS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameRibdam
Device classClass I
Regulation21 CFR 876.4560
Review panelGU — Gastroenterology and Urology
Medical specialtyGastroenterology, Urology
Premarket route510(k) exempt

Recalls for EYS devices

openFDA lists no recalls for product code EYS.

Frequently asked questions

What is FDA product code EYS?

EYS is the FDA product code for ribdam. It is a Class I device, regulated under 21 CFR 876.4560 and reviewed by the Gastroenterology and Urology panel.

What device class is EYS?

Class I, regulation 21 CFR 876.4560. Typical premarket route: 510(k) exempt.

Next steps

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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