GWM · Class II · 21 CFR 882.1620

FDA Product Code GWM: Device, Monitoring, Intracranial Pressure

Leading manufacturers include Codman & Shurtleff, Inc., Innerspace, Inc. and Raumedic AG.

105
Total
105
Cleared
149d
Avg days
1978
Since
105 devices
97–105 of 105
Cleared Sep 14, 1982
CLASS II DEVICE FOR I.C.P. MONITORING
K822636
Philadelphia Medical Specialties
Neurology · 14d
Cleared Dec 18, 1981
PHILLY BOLT
K813440
Philadelphia Medical Specialties
Neurology · 10d
Cleared Nov 12, 1980
TM-5 INTRACRANIAL PRESSURE MONITOR
K802149
Nicolet Biomedical Instruments
Neurology · 65d
Cleared Oct 31, 1980
CHEEK EPIDURAL SCREW
K802137
Codman & Shurtleff, Inc.
Neurology · 57d
Cleared Oct 31, 1980
CHEEK TOOL SET
K802138
Codman & Shurtleff, Inc.
Neurology · 57d
Cleared Sep 16, 1980
INTRACRANIAL PRESSURING MONITORING SYST.
K802100
Pudenz-Schulte Medical Research Corp.
Neurology · 13d
Cleared Aug 13, 1980
MMI/GAELTEC CATHETER TIP PRESSURE
K801755
Medical Measurements, Inc.
Neurology · 16d
Cleared Aug 03, 1979
INTRACRANIAL PRESSURE MONITORING
K790920
Codman & Shurtleff, Inc.
Neurology · 86d
Cleared Jan 03, 1978
CATHETER, INTRACRANIAL PRESS. MONITOR.
K772063
Cordis Corp.
Neurology · 62d