510(k) K080698

GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP by Senorx, Inc. — Product Code NEU

K080698 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP". The FDA issued a decision of Substantially Equivalent on March 31, 2008. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Senorx, Inc. has at least 10 other 510(k) clearances on record.