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., Coloplast and Hollister Incorporated.
FDA 510(k) Cleared Catheter, Straight Devices (Product Code EZD)
About Product Code EZD - Regulatory Context
510(k) Submission Activity
86 total 510(k) submissions under product code EZD since 1978, with 86 receiving FDA clearance (average review time: 157 days).
Submission volume has increased in recent years - 18 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - EZD Product Code
FDA review times for EZD submissions have been consistent, averaging 146 days recently vs 160 days historically.
EZD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →