510(k) K200247

Fusion Quattro Extraction Balloon by Wilson-Cook Medical, Inc. — Product Code GCA

K200247 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Fusion Quattro Extraction Balloon". The FDA issued a decision of Substantially Equivalent on February 27, 2020. The device falls under product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection), a Class II device regulated under 21 CFR 876.5010. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.