Device, Monitoring, Intracranial Pressure
FDA product code GWM · 103 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.1620
- Review panel
- NE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1978-01-03 – 2026-04-10
GWM
2026-04-10
GWM
2025-08-29
NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL
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GWM
2024-07-18
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
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GWM
2024-02-04
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
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GWM
2021-10-08
B4C System
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GWM
2021-04-30
CereLink ICP Monitor
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GWM
2020-05-26
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
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GWM
2020-04-09
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
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GWM
2020-03-26
Becker External Drainage and Monitoring System
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GWM
2019-10-17
BcSs-PICNI-2000 Sensor
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GWM
2019-01-11
CereLink ICP Monitor, CereLink ICP Extension Cable
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GWM
2018-05-18
AURA ICP MONITORING SYSTEM
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GWM
2017-11-08
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
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GWM
2017-07-06
MPR2 logO DATALOGGER
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GWM
2017-04-17
Pressio 2 ICP Monitoring System
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GWM
2016-10-20
HICP200 Patient/Monitor Interconnect Cable
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GWM
2016-08-19
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
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GWM
2016-01-22
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
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GWM
2013-10-25
RAUMEDIC-PTO-MONITORING-SYSTEM
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GWM
2013-08-30
INTEGRA LICOX PTO2 MONITOR
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GWM
2012-09-10
INTEGRA CAMINO ICP MONITOR
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GWM
2012-07-20
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
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GWM
2012-05-02
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
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GWM
2012-04-11
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
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GWM
2011-10-11
RAUMEDIC ICP MONITORING SYSTEM
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GWM
2011-03-04
RAUMEDIC- ICP-MONITORING SYSTEM
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GWM
2011-01-14
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
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GWM
2010-12-20
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
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GWM
2010-11-18
SENSOMETRICS SOFTWARE
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GWM
2009-09-29
SYNERGY
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GWM
2008-06-27
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
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GWM
2008-04-29
MPS OXIPORT AND MPS OXIPORT PLUS
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GWM
2007-08-06
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
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GWM
2007-07-05
PRESSIO ICP MONITORING SYSTEM
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GWM
2006-07-27
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
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GWM
2006-05-10
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
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GWM
2006-05-02
CMA CEREBRAL TISSUE MONITORING SYSTEM
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GWM
2005-07-19
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
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GWM
2005-05-17
NEUROSYSTEMS 1TM MONITOR
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GWM
2005-05-11
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
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GWM
2005-03-01
MPS (OR MPS-T)
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GWM
2004-10-22
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
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GWM
2004-04-20
LICOX PMO BRAIN MONITORING SYSTEM
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GWM
2003-10-21
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
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GWM
2003-05-14
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
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GWM
2002-10-31
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
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GWM
2002-10-23
CMA CEREBRAL TISSUE MONITORING SYSTEM
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GWM
2002-09-09
ACT III VENTRICULAR CATHETER
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GWM
2002-08-20
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
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GWM
2002-05-20
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
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GWM
2002-03-21
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
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GWM
2002-02-20
NEUROSENSOR
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GWM
2001-06-28
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
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GWM
2001-06-28
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
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GWM
2001-06-15
ACTI-ICP MONITORING SYSTEM
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GWM
2000-11-24
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
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GWM
2000-11-02
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
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GWM
1999-10-15
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
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GWM
1999-07-14
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
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GWM
1999-07-09
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
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GWM
1999-01-26
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
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GWM
1998-09-10
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
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GWM
1998-08-18
PARENCHYMAL BOLT PRESSURE MONITORING KIT
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GWM
1998-01-09
CODMAN INTRACRANIAL BOLT
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GWM
1996-12-20
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
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GWM
1995-10-26
COMAN(R) CU-11 MODEL NUMBER 82-6634
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GWM
1995-09-26
CHARTR ENG SYSTEM
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GWM
1995-03-01
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
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GWM
1994-12-07
OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE
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GWM
1994-03-07
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
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GWM
1993-04-15
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
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GWM
1992-03-25
MODEL 704
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GWM
1992-01-17
VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
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GWM
1990-07-03
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
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GWM
1990-02-23
MODEL BT-1 FOT BOLT INSTALLATION KIT
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GWM
1989-11-22
MINI-MONITOR J7000 ICP
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GWM
1989-04-26
MODEL FT-100 INTRACRANIAL PRESSURE MONITOR
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GWM
1988-10-27
MODIFIED MODEL 2001 FIBER OPTICS CATHETER
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GWM
1988-09-22
EVENT MARKER & A SECOND PRESSURE TREND OUTPUT
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GWM
1988-09-08
METATECH ROBINSON BOLT ACCESSORY
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GWM
1988-08-29
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
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GWM
1988-07-18
EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET
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GWM
1988-05-04
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
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GWM
1988-03-28
METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM
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GWM
1987-02-26
LADD/STERITEK ICP MONITOR, CAT. NO. P3000
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GWM
1986-10-14
MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
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GWM
1986-10-06
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
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GWM
1986-06-09
LADD MEDICAL S-2000
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GWM
1986-02-20
INTRACRANIAL PRESSURE MONITORING KIT 070
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GWM
1985-12-27
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
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GWM
1985-08-16
ICP MONITOR MODEL 1000
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GWM
1984-04-04
PHILLY INFANT BOLT
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GWM
1984-02-28
DISPOSABLE ICP KIT DIFF. SIZES
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GWM
1982-11-16
INTRACRANIAL PRESSURE MONITORING DEVICE
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GWM
1982-09-14
CLASS II DEVICE FOR I.C.P. MONITORING
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GWM
1981-12-18
PHILLY BOLT
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GWM
1980-11-12
TM-5 INTRACRANIAL PRESSURE MONITOR
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GWM
1980-10-31
CHEEK TOOL SET
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GWM
1980-10-31
CHEEK EPIDURAL SCREW
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GWM
1980-09-16
INTRACRANIAL PRESSURING MONITORING SYST.
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