510(k) K191341

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags by Corinth Medtech, Inc. — Product Code FJL

K191341 is an FDA 510(k) premarket notification submitted by Corinth Medtech, Inc. for the device "Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags". The FDA issued a decision of Substantially Equivalent on June 13, 2019. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. Corinth Medtech, Inc. has at least 6 other 510(k) clearances on record.