510(k) K131654

STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER by Senorx, Inc. — Product Code NEU

K131654 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER". The FDA issued a decision of Substantially Equivalent on June 27, 2013. 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.