510(k) K132436

VARIOGUIDE DRILL KIT by Mri Interventions, Inc. — Product Code HBE

K132436 is an FDA 510(k) premarket notification submitted by Mri Interventions, Inc. for the device "VARIOGUIDE DRILL KIT". The FDA issued a decision of Substantially Equivalent on March 20, 2014. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Mri Interventions, Inc. has at least 10 other 510(k) clearances on record.