510(k) K191684

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System by Integra LifeSciences Corporation — Product Code JXG

K191684 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System". The FDA issued a decision of Substantially Equivalent on October 11, 2019. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.