ClearanceBrief
Panels › Neurology › Product code GWM · Class 2

Device, Monitoring, Intracranial Pressure

Regulation 882.1620

1510(k)s in 12 months (105 all time)
3recalls in 12 months (52 all time)
47recalls that name a 510(k)
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Top companies in GWM

Company510(k)sRecalls
Integra LifeSciences Corporation826
Codman & Shurtleff, Inc.912
Innerspace, Inc.70
Raumedic AG60
Sophysa33
Integra Neurosciences50
Metatech Corp.50
Camino Laboratories, Inc.40
Cma Microdialysis AB40
Camino Neurocare, Inc.30
Decided510(k)Device and applicantCode
Apr 10, 2026K252241Pressio 3 Multi-parameter Neuromonitoring System
Sophysa, FR
GWM
Aug 29, 2025K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-
Raumedic AG, DE
GWM
Jul 18, 2024K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
Braincare Desenvolvimento E Inovação Tecnológica S.A., BR
GWM
Feb 4, 2024K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
Integra Lifesciences Production Corporation
GWM
Oct 8, 2021K201989B4C System
Braincare Desenvolvimento E Inovacao Tecnologica S.A., BR
GWM
Apr 30, 2021K210993CereLink ICP Monitor
Integra Lifesciences Production Corporation
GWM
May 26, 2020K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Re
Medtronic, Inc.
GWM
Apr 9, 2020K200630Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement
Medtronic, Inc.
GWM
Mar 26, 2020K200456Becker External Drainage and Monitoring System
Medtronic, Inc.
GWM
Oct 17, 2019K182073BcSs-PICNI-2000 Sensor
Braincare Desenvolvimento E Inovacao Tecnologica S.A., BR
GWM
Jan 11, 2019K183406CereLink ICP Monitor, CereLink ICP Extension Cable
Integra Lifesciences Corp.
GWM
May 18, 2018K172209AURA ICP MONITORING SYSTEM
Branchpoint Technologies, Inc.
GWM
Nov 8, 2017K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, Cer
Codman & Shurtleff, Inc.
GWM
Jul 6, 2017K171666MPR2 logO DATALOGGER
Raumedic AG, DE
GWM
Apr 17, 2017K162108Pressio 2 ICP Monitoring System
Sophysa SA, FR
GWM
Oct 20, 2016K161010HICP200 Patient/Monitor Interconnect Cable
Innerspace Neuro Solutions, Inc.
GWM
Aug 19, 2016K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit wit
Codman & Shurtleff, Inc.
GWM
Jan 22, 2016K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
Medos International SARL, CH
GWM
Oct 10, 2014K141869QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
Hemedex Incorporated
GWM
Mar 6, 2014K133754INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
Integra LifeSciences Corporation
GWM
Oct 25, 2013K130529RAUMEDIC-PTO-MONITORING-SYSTEM
Raumedic AG, DE
GWM
Aug 30, 2013K131184INTEGRA LICOX PTO2 MONITOR
Integra Lifesciences Corp.
GWM
Sep 10, 2012K121573INTEGRA CAMINO ICP MONITOR
Intrgra Lifesciences Corporation
GWM
Jul 20, 2012K121159INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
Integra Lifescience Corportation
GWM
May 2, 2012K113088HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
Innerspace, Inc.
GWM
Apr 11, 2012K120252RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
Raumedic AG, DE
GWM
Oct 11, 2011K112017RAUMEDIC ICP MONITORING SYSTEM
Raumedic AG, DE
GWM
Mar 4, 2011K103206RAUMEDIC- ICP-MONITORING SYSTEM
Raumedic AG, DE
GWM
Jan 14, 2011K102077MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
Cma Microdialysis AB
GWM
Dec 20, 2010K102875CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
Integra LifeSciences Corporation
GWM
Nov 18, 2010K101133SENSOMETRICS SOFTWARE
Dpcom AS
GWM
Sep 29, 2009K083378SYNERGY
Innerspace, Inc.
GWM
Jun 27, 2008K071984MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
Cma Microdialysis AB
GWM
Apr 29, 2008K072379MPS OXIPORT AND MPS OXIPORT PLUS
Innerspace, Inc.
GWM
Aug 6, 2007K071505MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
Integra LifeSciences Corporation
GWM
Jul 5, 2007K062584PRESSIO ICP MONITORING SYSTEM
Sophysa SA
GWM
Jul 27, 2006K061640INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
Integra LifeSciences Corporation
GWM
May 10, 2006K053244LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
Integra Lifesciences Corp.
GWM
May 2, 2006K060554CMA CEREBRAL TISSUE MONITORING SYSTEM
Cma Microdialysis AB
GWM
Jul 19, 2005K051599NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
Neurorecovery, Inc.
GWM
May 17, 2005K050702NEUROSYSTEMS 1TM MONITOR
Neurosystems, LLC
GWM
May 11, 2005K050720NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
Integra Neurosciences
GWM
Mar 1, 2005K041838MPS (OR MPS-T)
Innerspace, Inc.
GWM
Oct 22, 2004K042728CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
Novus Monitoring, Ltd.
GWM
Apr 20, 2004K040235LICOX PMO BRAIN MONITORING SYSTEM
Integra LifeSciences Corporation
GWM
Oct 21, 2003K032337HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
Hemedex Incorporated
GWM
May 14, 2003K031086CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
Integra Neurosciences
GWM
Oct 31, 2002K022638NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
Neurorecovery, Inc.
GWM
Oct 23, 2002K020285CMA CEREBRAL TISSUE MONITORING SYSTEM
Cma Microdialysis AB
GWM
Sep 9, 2002K013705ACT III VENTRICULAR CATHETER
Innerspace, Inc.
GWM

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