510(k) K241424

InnoCare Specialty Foley Catheter by Innocare Urologics, LLC — Product Code EZL

K241424 is an FDA 510(k) premarket notification submitted by Innocare Urologics, LLC for the device "InnoCare Specialty Foley Catheter". The FDA issued a decision of Substantially Equivalent on September 18, 2024. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130.