510(k) K190099

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

K190099 is an FDA 510(k) premarket notification submitted by Corinth Medtech, Inc. for the device "Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch". The FDA issued a decision of Substantially Equivalent on March 15, 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.