510(k) K153347

Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit by Codman & Shurtleff, Inc. — Product Code GWM

K153347 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit". The FDA issued a decision of Substantially Equivalent on August 19, 2016. 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.