GWM · Class II · 21 CFR 882.1620

FDA Product Code GWM: Device, Monitoring, Intracranial Pressure

Leading manufacturers include Codman & Shurtleff, Inc., Raumedic AG and Integra LifeSciences Corporation.

105
Total
105
Cleared
149d
Avg days
1978
Since
105 devices
25–48 of 105
Cleared May 02, 2012
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
K113088
Innerspace, Inc.
Neurology · 196d
Cleared Apr 11, 2012
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
K120252
Raumedic AG
Neurology · 75d
Cleared Oct 11, 2011
RAUMEDIC ICP MONITORING SYSTEM
K112017
Raumedic AG
Neurology · 89d
Cleared Dec 20, 2010
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875
Integra LifeSciences Corporation
Neurology · 80d
Cleared Aug 06, 2007
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K071505
Integra LifeSciences Corporation
Neurology · 66d
Cleared Jul 27, 2006
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K061640
Integra LifeSciences Corporation
Neurology · 45d
Cleared May 10, 2006
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
K053244
Integra Lifesciences Corp.
Neurology · 170d
Cleared Jul 19, 2005
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
K051599
Neurorecovery, Inc.
Neurology · 33d
Cleared May 17, 2005
NEUROSYSTEMS 1TM MONITOR
K050702
Neurosystems, LLC
Neurology · 60d
Cleared May 11, 2005
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
K050720
Integra Neurosciences
Neurology · 51d
Cleared Mar 01, 2005
MPS (OR MPS-T)
K041838
Innerspace, Inc.
Neurology · 237d
Cleared Oct 22, 2004
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
K042728
Novus Monitoring, Ltd.
Neurology · 21d
Cleared Apr 20, 2004
LICOX PMO BRAIN MONITORING SYSTEM
K040235
Integra LifeSciences Corporation
Neurology · 78d
Cleared May 20, 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780
Medex, Inc.
Neurology · 70d
Cleared Jun 28, 2001
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759
Aesculap, Inc.
Neurology · 204d
Cleared Oct 15, 1999
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591
Codman & Shurtleff, Inc.
Neurology · 74d
Cleared Jul 14, 1999
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
K980380
Diametrics Medical, Ltd.
Neurology · 527d
Cleared Jul 09, 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222
Johnson & Johnson Professionals, Inc.
Neurology · 88d
Cleared Jan 26, 1999
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
K983799
Medtronic PS Medical
Neurology · 90d
Cleared Sep 10, 1998
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
K982702
Camino Neurocare, Inc.
Neurology · 38d
Cleared Aug 18, 1998
PARENCHYMAL BOLT PRESSURE MONITORING KIT
K981846
Camino Neurocare, Inc.
Neurology · 84d
Cleared Jan 09, 1998
CODMAN INTRACRANIAL BOLT
K974088
Johnson & Johnson Professionals, Inc.
Neurology · 71d
Cleared Dec 20, 1996
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
K962928
Camino Neurocare, Inc.
Neurology · 144d
Cleared Oct 26, 1995
COMAN(R) CU-11 MODEL NUMBER 82-6634
K945585
Johnson & Johnson Professionals, Inc.
Neurology · 346d