510(k) K153281

BrightMatter Guide with Surface Trace Registration by Synaptive Medical, Inc. — Product Code HAW

K153281 is an FDA 510(k) premarket notification submitted by Synaptive Medical, Inc. for the device "BrightMatter Guide with Surface Trace Registration". The FDA issued a decision of Substantially Equivalent on March 30, 2016. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Synaptive Medical, Inc. has at least 9 other 510(k) clearances on record.