510(k) K160129

MRII Cranial Drill and Accessories by Mri Interventions, Inc. — Product Code HBG

K160129 is an FDA 510(k) premarket notification submitted by Mri Interventions, Inc. for the device "MRII Cranial Drill and Accessories". The FDA issued a decision of Substantially Equivalent on March 26, 2016. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Mri Interventions, Inc. has at least 10 other 510(k) clearances on record.