510(k) K173657

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter by Cook Incorporated — Product Code EZL

K173657 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter". The FDA issued a decision of Substantially Equivalent on Aug 23, 2018. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Cook Incorporated has 174 other 510(k) clearances on record.