510(k) K173192

CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit by Codman & Shurtleff, Inc. — Product Code GWM

K173192 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit". The FDA issued a decision of Substantially Equivalent on November 8, 2017. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.