510(k) K183406

CereLink ICP Monitor, CereLink ICP Extension Cable by Integra Lifesciences Corp. — Product Code GWM

K183406 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "CereLink ICP Monitor, CereLink ICP Extension Cable". The FDA issued a decision of Substantially Equivalent on January 11, 2019. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.