510(k) K191061

Optilume Basic Urological Balloon Dilation Catheter by Urotronic, Inc. — Product Code KOE

K191061 is an FDA 510(k) premarket notification submitted by Urotronic, Inc. for the device "Optilume Basic Urological Balloon Dilation Catheter". The FDA issued a decision of Substantially Equivalent on January 2, 2020. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Urotronic, Inc. has at least 1 other 510(k) clearance on record.