FDA Product Code EZL: Catheter, Retention Type, Balloon
FDA product code EZL covers balloon retention catheters used for urinary drainage.
These Foley-type catheters have an inflatable balloon near the tip that holds the catheter in the bladder after insertion, providing continuous urinary drainage for days to weeks. They are used in urinary retention, perioperative monitoring, and incontinent patients requiring prolonged bladder management.
EZL devices are Class II medical devices, regulated under 21 CFR 876.5130 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Teleflexmedical, Inc. and Coloplast Corp..
List of Catheter, Retention Type, Balloon devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheter, Retention Type, Balloon devices (product code EZL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →