510(k) K171596

ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle by Wilson-Cook Medical, Inc. — Product Code FCG

K171596 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle". The FDA issued a decision of Substantially Equivalent on August 4, 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.