510(k) K081085

STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS by Senorx, Inc. — Product Code NEU

K081085 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS". The FDA issued a decision of Substantially Equivalent on August 1, 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.