510(k) K160523

BrightMatter Guide with BrightMatter Pointer by Synaptive Medical, Inc. — Product Code HAW

K160523 is an FDA 510(k) premarket notification submitted by Synaptive Medical, Inc. for the device "BrightMatter Guide with BrightMatter Pointer". The FDA issued a decision of Substantially Equivalent on June 24, 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.