510(k) K111895

ECHOTIP(R) ULTRA FIDUCIAL NEEDLE by Wilson-Cook Medical Inc./Cook Endoscopy — Product Code NEU

K111895 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical Inc./Cook Endoscopy for the device "ECHOTIP(R) ULTRA FIDUCIAL NEEDLE". The FDA issued a decision of Substantially Equivalent on April 27, 2012. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Wilson-Cook Medical Inc./Cook Endoscopy has at least 6 other 510(k) clearances on record.