510(k) K193344

Tri-Ex Extraction Balloon with Multiple Sizing by Wilson-Cook Medical, Inc. — Product Code GCA

K193344 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Tri-Ex Extraction Balloon with Multiple Sizing". The FDA issued a decision of Substantially Equivalent on December 13, 2019. 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.