510(k) K121964

MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML by Augmenix, Inc. — Product Code NEU

K121964 is an FDA 510(k) premarket notification submitted by Augmenix, Inc. for the device "MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML". The FDA issued a decision of Substantially Equivalent on January 23, 2013. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Augmenix, Inc. has at least 4 other 510(k) clearances on record.