510(k) K250910

Optilume® High Pressure Urological Balloon Dilation Catheter by Urotronic, Inc. — Product Code EZN

K250910 is an FDA 510(k) premarket notification submitted by Urotronic, Inc. for the device "Optilume® High Pressure Urological Balloon Dilation Catheter". The FDA issued a decision of Substantially Equivalent on May 22, 2025. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Urotronic, Inc. has at least 1 other 510(k) clearance on record.