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., Guangdong Ecan Medical Co., Ltd. and Teleflex Medical Sdn. Bhd..
FDA 510(k) Cleared Catheter, Retention Type, Balloon Devices (Product Code EZL)
About Product Code EZL - Regulatory Context
510(k) Submission Activity
128 total 510(k) submissions under product code EZL since 1977, with 128 receiving FDA clearance (average review time: 167 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 8 in the prior period.
FDA Review Time
Recent submissions under EZL have taken an average of 224 days to reach a decision - up from 167 days historically. Manufacturers should account for longer review timelines in current project planning.
EZL devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →