510(k) K220722

PVC Hydrophilic Urethral Catheter by Well Lead Medical Co., Ltd. — Product Code EZD

K220722 is an FDA 510(k) premarket notification submitted by Well Lead Medical Co., Ltd. for the device "PVC Hydrophilic Urethral Catheter". The FDA issued a decision of Substantially Equivalent on May 22, 2023. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Well Lead Medical Co., Ltd. has at least 10 other 510(k) clearances on record.