510(k) K192908

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes by Wilson-Cook Medical, Inc. — Product Code FDX

K192908 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes". The FDA issued a decision of Substantially Equivalent on November 14, 2019. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.