510(k) K181622

StrataMR guider tool by Medtronic Neurosurgery — Product Code JXG

K181622 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "StrataMR guider tool". The FDA issued a decision of Substantially Equivalent on October 1, 2018. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.