510(k) K151536

SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm by Mri Interventions, Inc. — Product Code HBG

K151536 is an FDA 510(k) premarket notification submitted by Mri Interventions, Inc. for the device "SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm". The FDA issued a decision of Substantially Equivalent on July 8, 2015. 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.