510(k) K013120

PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 by Medamicus, Inc. — Product Code GZB

K013120 is an FDA 510(k) premarket notification submitted by Medamicus, Inc. for the device "PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18". The FDA issued a decision of Substantially Equivalent on January 24, 2002. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Medamicus, Inc. has at least 10 other 510(k) clearances on record.