510(k) K173654

Ureteral Dilator Sets, Ureteral Dilators by Cook Incorporated — Product Code EZN

K173654 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Ureteral Dilator Sets, Ureteral Dilators". The FDA issued a decision of Substantially Equivalent on July 17, 2018. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Cook Incorporated has at least 10 other 510(k) clearances on record.