510(k) K112214

OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS by St. Jude Medical Neuromodulation — Product Code GZB

K112214 is an FDA 510(k) premarket notification submitted by St. Jude Medical Neuromodulation for the device "OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS". The FDA issued a decision of Substantially Equivalent on November 17, 2011. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. St. Jude Medical Neuromodulation has at least 1 other 510(k) clearance on record.