FDA Product Code EZD: Catheter, Straight
Under FDA product code EZD, straight urological catheters are cleared for bladder drainage and urinary tract access.
These single-lumen catheters are inserted through the urethra into the bladder to drain urine in patients with urinary retention or obstruction, or to deliver irrigant solutions. Straight catheters are used for intermittent self-catheterization and short-term drainage.
EZD devices are Class II medical devices, regulated under 21 CFR 876.5130 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Coloplast Corp., Dentsply Sirona and Coloplast.
FDA 510(k) Cleared Catheter, Straight Devices (Product Code EZD)
About Product Code EZD - Regulatory Context
510(k) Submission Activity
81 total 510(k) submissions under product code EZD since 1978, with 81 receiving FDA clearance (average review time: 160 days).
Submission volume has remained relatively stable over the observed period, with 14 submissions in the last 24 months.
FDA Review Time
FDA review times for EZD submissions have been consistent, averaging 152 days recently vs 161 days historically.
EZD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →