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., Sentinel Medical Technologies, LLC and Innocare Urologics, LLC.