510(k) K153763

Howell Biliary Aspiration Needle by Wilson-Cook Medical, Inc. — Product Code FCK

K153763 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Howell Biliary Aspiration Needle". The FDA issued a decision of Substantially Equivalent on April 6, 2017. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.