FDA 510(k) Applications for Medical Device Product Code "GWM"
(Device, Monitoring, Intracranial Pressure)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K003759 | AESCULAP, INC. | AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR | 06/28/2001 |
| K201989 | Braincare Desenvolvimento e Inovacao Tecnologica S.A. | B4C System | 10/08/2021 |
| K182073 | Braincare desenvolvimento e Inovacao Tecnologica S.A. | BcSs-PICNI-2000 Sensor | 10/17/2019 |
| K172209 | Branchpoint Technologies, INC. | AURA ICP MONITORING SYSTEM | 05/18/2018 |
| K962928 | CAMINO NEUROCARE, INC. | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) | 12/20/1996 |
| K981846 | CAMINO NEUROCARE, INC. | PARENCHYMAL BOLT PRESSURE MONITORING KIT | 08/18/1998 |
| K982702 | CAMINO NEUROCARE, INC. | VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD | 09/10/1998 |
| K020285 | CMA MICRODIALYSIS AB | CMA CEREBRAL TISSUE MONITORING SYSTEM | 10/23/2002 |
| K060554 | CMA MICRODIALYSIS AB | CMA CEREBRAL TISSUE MONITORING SYSTEM | 05/02/2006 |
| K071984 | CMA MICRODIALYSIS AB | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM | 06/27/2008 |
| K102077 | CMA MICRODIALYSIS AB | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM | 01/14/2011 |
| K173192 | Codman & Shurtleff, Inc | 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 | 11/08/2017 |
| K153347 | CODMAN & SHURTLEFF, INC. | 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 | 08/19/2016 |
| K992591 | Codman & Shurtleff, Inc. | CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS | 10/15/1999 |
| K980380 | DIAMETRICS MEDICAL, LTD. | NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS | 07/14/1999 |
| K101133 | DPCOM AS | SENSOMETRICS SOFTWARE | 11/18/2010 |
| K032337 | HEMEDEX INCORPORATED | HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 | 10/21/2003 |
| K141869 | HEMEDEX INCORPORATED | QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT | 10/10/2014 |
| K161010 | InnerSpace Neuro Solutions, Inc. | HICP200 Patient/Monitor Interconnect Cable | 10/20/2016 |
| K113088 | INNERSPACE, INC | HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) | 05/02/2012 |
| K010422 | INNERSPACE, INC. | ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER | 06/28/2001 |
| K013705 | INNERSPACE, INC. | ACT III VENTRICULAR CATHETER | 09/09/2002 |
| K003905 | INNERSPACE, INC. | ACTI-ICP MONITORING SYSTEM | 06/15/2001 |
| K041838 | INNERSPACE, INC. | MPS (OR MPS-T) | 03/01/2005 |
| K072379 | INNERSPACE, INC. | MPS OXIPORT AND MPS OXIPORT PLUS | 04/29/2008 |
| K083378 | INNERSPACE, INC. | SYNERGY | 09/29/2009 |
| K121159 | INTEGRA LIFESCIENCE CORPORTATION | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER | 07/20/2012 |
| K183406 | Integra LifeSciences Corp. | CereLink ICP Monitor, CereLink ICP Extension Cable | 01/11/2019 |
| K131184 | INTEGRA LIFESCIENCES CORP. | INTEGRA LICOX PTO2 MONITOR | 08/30/2013 |
| K053244 | INTEGRA LIFESCIENCES CORP. | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT | 05/10/2006 |
| K102875 | INTEGRA LIFESCIENCES CORPORATION | CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C | 12/20/2010 |
| K133754 | INTEGRA LIFESCIENCES CORPORATION | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER | 03/06/2014 |
| K061640 | INTEGRA LIFESCIENCES CORPORATION | INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM | 07/27/2006 |
| K040235 | INTEGRA LIFESCIENCES CORPORATION | LICOX PMO BRAIN MONITORING SYSTEM | 04/20/2004 |
| K071505 | INTEGRA LIFESCIENCES CORPORATION | MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM | 08/06/2007 |
| K210993 | Integra LifeSciences Production Corporation | CereLink ICP Monitor | 04/30/2021 |
| K031086 | INTEGRA NEURO SCIENCES | CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 | 05/14/2003 |
| K002392 | INTEGRA NEUROCARE LLC. | VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V | 11/02/2000 |
| K022553 | INTEGRA NEUROSCIENCES | CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L | 08/20/2002 |
| K020558 | INTEGRA NEUROSCIENCES | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE | 03/21/2002 |
| K002765 | INTEGRA NEUROSCIENCES | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE | 11/24/2000 |
| K050720 | INTEGRA NEUROSCIENCES | NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 | 05/11/2005 |
| K121573 | INTRGRA LIFESCIENCES CORPORATION | INTEGRA CAMINO ICP MONITOR | 09/10/2012 |
| K974088 | JOHNSON & JOHNSON PROFESSIONALS, INC. | CODMAN INTRACRANIAL BOLT | 01/09/1998 |
| K991222 | JOHNSON & JOHNSON PROFESSIONALS, INC. | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | 07/09/1999 |
| K020780 | MEDEX, INC. | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | 05/20/2002 |
| K152670 | Medos International SARL | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables | 01/22/2016 |
| K983799 | MEDTRONIC PS MEDICAL | MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL | 01/26/1999 |
| K200456 | Medtronic, Inc. | Becker External Drainage and Monitoring System | 03/26/2020 |
| K201118 | Medtronic, Inc. | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | 05/26/2020 |
| K200630 | Medtronic, Inc. | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | 04/09/2020 |
| K022638 | NEURORECOVERY, INC. | NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT | 10/31/2002 |
| K051599 | NEURORECOVERY, INC. | NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT | 07/19/2005 |
| K050702 | NEUROSYSTEMS LLC | NEUROSYSTEMS 1TM MONITOR | 05/17/2005 |
| K042728 | NOVUS MONITORING LTD | CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM | 10/22/2004 |
| K013930 | NOVUS MONITORING LTD | NEUROSENSOR | 02/20/2002 |
| K171666 | Raumedic AG | MPR2 logO DATALOGGER | 07/06/2017 |
| K112017 | RAUMEDIC AG | RAUMEDIC ICP MONITORING SYSTEM | 10/11/2011 |
| K103206 | RAUMEDIC AG | RAUMEDIC- ICP-MONITORING SYSTEM | 03/04/2011 |
| K120252 | RAUMEDIC AG | RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM | 04/11/2012 |
| K130529 | RAUMEDIC AG | RAUMEDIC-PTO-MONITORING-SYSTEM | 10/25/2013 |
| K062584 | SOPHYSA SA | PRESSIO ICP MONITORING SYSTEM | 07/05/2007 |
| K162108 | SOPHYSA, SA | Pressio 2 ICP Monitoring System | 04/17/2017 |
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