510(k) K160890

Howell Biliary Introducer Needle by Wilson-Cook Medical, Inc. — Product Code FCG

K160890 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Howell Biliary Introducer Needle". The FDA issued a decision of Substantially Equivalent on June 14, 2017. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.