510(k) K142688

Echotip Procore HD Ultrasound Biopsy Needle by Cook Ireland, Ltd. — Product Code FCG

K142688 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "Echotip Procore HD Ultrasound Biopsy Needle". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Cook Ireland, Ltd. has at least 10 other 510(k) clearances on record.