510(k) K180756

Safety Wire Guide Introducer by Cook Incorporated — Product Code EZN

K180756 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Safety Wire Guide Introducer". The FDA issued a decision of Substantially Equivalent on May 24, 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.