510(k) K191335

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 HIH

K191335 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 6, 2019. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Corinth Medtech, Inc. has at least 6 other 510(k) clearances on record.