510(k) K251274

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits by HR Healthcare — Product Code EZD

K251274 is an FDA 510(k) premarket notification submitted by HR Healthcare for the device "EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits". The FDA issued a decision of Substantially Equivalent (kit) on January 29, 2026. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. HR Healthcare has at least 1 other 510(k) clearance on record.