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., Convatec and Hollister Incorporated.