510(k) K022554

MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM by Integra Neurosciences — Product Code JXG

K022554 is an FDA 510(k) premarket notification submitted by Integra Neurosciences for the device "MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 23, 2002. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Integra Neurosciences has at least 8 other 510(k) clearances on record.