FDA product code EYK: Connector, Ureteral Catheter

EYK is the FDA product code for connector, ureteral catheter. It is a Class I device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under EYK. The average 510(k) review took 254 days (median 254).

Classification

Compare with all 510(k) review times · Search every EYK clearance

Top EYK applicants

Most recent EYK clearances

Recalls for EYK devices

openFDA lists no recalls for product code EYK.

Frequently asked questions

What is FDA product code EYK?

EYK is the FDA product code for connector, 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 EYK?

Class I, regulation 21 CFR 876.5130. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code EYK?

Across 1 cleared submissions the average was 254 days from receipt to decision (median 254).

Which companies have the most EYK clearances?

Urological Associates of Central Jersey P.A. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code EYK
• Run a recall and safety report across every EYK manufacturer
• Watch product code EYK 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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