Product Code: GWM
FDA class 2
21 CFR 882.1620
Device, Monitoring, Intracranial Pressure
Neurology
The Device, Monitoring, Intracranial Pressure is a neurological monitoring instrument used to continuously measure and record intracranial pressure (ICP), a critical parameter in managing patients with traumatic brain injury, stroke, hydrocephalus, and other neurological conditions. It is an FDA Class 2 device, indicating moderate risk and requiring 510(k) premarket notification. Regulated under 21 CFR 882.1620 with product code GWM in the Neurology specialty. This device is eligible for third-party 510(k) review.
510(k)s
103
FEI Numbers
63
Registration Numbers
64
Unique Applicants
52
Years Active
47
Basic Information
- Product Code
- GWM
- Device Class
- FDA class 2
- Regulation Number
- 882.1620
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 103 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Jul 18, 2024 | Substantially Equivalent | Braincare Desenvolvimento e Inovação Tecnológica S.A. |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | Feb 04, 2024 | Substantially Equivalent | Integra LifeSciences Production Corporation |
| K201989 | B4C System | Oct 08, 2021 | Substantially Equivalent | Braincare Desenvolvimento e Inovacao Tecnologica S.A. |
| K210993 | CereLink ICP Monitor | Apr 30, 2021 | Substantially Equivalent | Integra LifeSciences Production Corporation |
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | May 26, 2020 | Substantially Equivalent | Medtronic, Inc. |
| K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | Apr 09, 2020 | Substantially Equivalent | Medtronic, Inc. |
| K200456 | Becker External Drainage and Monitoring System | Mar 26, 2020 | Substantially Equivalent | Medtronic, Inc. |
| K182073 | BcSs-PICNI-2000 Sensor | Oct 17, 2019 | Substantially Equivalent | Braincare desenvolvimento e Inovacao Tecnologica S.A. |
| K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable | Jan 11, 2019 | Substantially Equivalent | Integra LifeSciences Corp. |
| K172209 | AURA ICP MONITORING SYSTEM | May 18, 2018 | Substantially Equivalent | Branchpoint Technologies, INC. |
| K173192 | 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 | Nov 08, 2017 | Substantially Equivalent | Codman & Shurtleff, Inc |
| K171666 | MPR2 logO DATALOGGER | Jul 06, 2017 | Substantially Equivalent | Raumedic AG |
| K162108 | Pressio 2 ICP Monitoring System | Apr 17, 2017 | Substantially Equivalent | SOPHYSA, SA |
| K161010 | HICP200 Patient/Monitor Interconnect Cable | Oct 20, 2016 | Substantially Equivalent | InnerSpace Neuro Solutions, Inc. |
| K153347 | 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 | Aug 19, 2016 | Substantially Equivalent | CODMAN & SHURTLEFF, INC. |
| K152670 | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables | Jan 22, 2016 | Substantially Equivalent | Medos International SARL |
| K141869 | QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT | Oct 10, 2014 | Substantially Equivalent | HEMEDEX INCORPORATED |
| K133754 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER | Mar 06, 2014 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K130529 | RAUMEDIC-PTO-MONITORING-SYSTEM | Oct 25, 2013 | Substantially Equivalent | RAUMEDIC AG |
| K131184 | INTEGRA LICOX PTO2 MONITOR | Aug 30, 2013 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K121573 | INTEGRA CAMINO ICP MONITOR | Sep 10, 2012 | Substantially Equivalent | INTRGRA LIFESCIENCES CORPORATION |
| K121159 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER | Jul 20, 2012 | Substantially Equivalent | INTEGRA LIFESCIENCE CORPORTATION |
| K113088 | HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) | May 02, 2012 | Substantially Equivalent | INNERSPACE, INC |
| K120252 | RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM | Apr 11, 2012 | Substantially Equivalent | RAUMEDIC AG |
| K112017 | RAUMEDIC ICP MONITORING SYSTEM | Oct 11, 2011 | Substantially Equivalent | RAUMEDIC AG |
| K103206 | RAUMEDIC- ICP-MONITORING SYSTEM | Mar 04, 2011 | Substantially Equivalent | RAUMEDIC AG |
| K102077 | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM | Jan 14, 2011 | Substantially Equivalent | CMA MICRODIALYSIS AB |
| K102875 | CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C | Dec 20, 2010 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K101133 | SENSOMETRICS SOFTWARE | Nov 18, 2010 | Substantially Equivalent | DPCOM AS |
| K083378 | SYNERGY | Sep 29, 2009 | Substantially Equivalent | INNERSPACE, INC. |
| K071984 | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM | Jun 27, 2008 | Substantially Equivalent | CMA MICRODIALYSIS AB |
| K072379 | MPS OXIPORT AND MPS OXIPORT PLUS | Apr 29, 2008 | Substantially Equivalent | INNERSPACE, INC. |
| K071505 | MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM | Aug 06, 2007 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K062584 | PRESSIO ICP MONITORING SYSTEM | Jul 05, 2007 | Substantially Equivalent | SOPHYSA SA |
| K061640 | INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM | Jul 27, 2006 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K053244 | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT | May 10, 2006 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K060554 | CMA CEREBRAL TISSUE MONITORING SYSTEM | May 02, 2006 | Substantially Equivalent | CMA MICRODIALYSIS AB |
| K051599 | NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT | Jul 19, 2005 | Substantially Equivalent | NEURORECOVERY, INC. |
| K050702 | NEUROSYSTEMS 1TM MONITOR | May 17, 2005 | Substantially Equivalent | NEUROSYSTEMS LLC |
| K050720 | NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 | May 11, 2005 | Substantially Equivalent | INTEGRA NEUROSCIENCES |
| K041838 | MPS (OR MPS-T) | Mar 01, 2005 | Substantially Equivalent | INNERSPACE, INC. |
| K042728 | CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM | Oct 22, 2004 | Substantially Equivalent | NOVUS MONITORING LTD |
| K040235 | LICOX PMO BRAIN MONITORING SYSTEM | Apr 20, 2004 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K032337 | HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 | Oct 21, 2003 | Substantially Equivalent | HEMEDEX INCORPORATED |
| K031086 | CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 | May 14, 2003 | Substantially Equivalent | INTEGRA NEURO SCIENCES |
| K022638 | NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT | Oct 31, 2002 | Substantially Equivalent | NEURORECOVERY, INC. |
| K020285 | CMA CEREBRAL TISSUE MONITORING SYSTEM | Oct 23, 2002 | Substantially Equivalent | CMA MICRODIALYSIS AB |
| K013705 | ACT III VENTRICULAR CATHETER | Sep 09, 2002 | Substantially Equivalent | INNERSPACE, INC. |
| K022553 | CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L | Aug 20, 2002 | Substantially Equivalent | INTEGRA NEUROSCIENCES |
| K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | May 20, 2002 | Substantially Equivalent | MEDEX, INC. |
| K020558 | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE | Mar 21, 2002 | Substantially Equivalent | INTEGRA NEUROSCIENCES |
| K013930 | NEUROSENSOR | Feb 20, 2002 | Substantially Equivalent | NOVUS MONITORING LTD |
| K010422 | ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER | Jun 28, 2001 | Substantially Equivalent | INNERSPACE, INC. |
| K003759 | AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR | Jun 28, 2001 | Substantially Equivalent | AESCULAP, INC. |
| K003905 | ACTI-ICP MONITORING SYSTEM | Jun 15, 2001 | Substantially Equivalent | INNERSPACE, INC. |
| K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE | Nov 24, 2000 | Substantially Equivalent | INTEGRA NEUROSCIENCES |
| K002392 | VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V | Nov 02, 2000 | Substantially Equivalent | INTEGRA NEUROCARE LLC. |
| K992591 | CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS | Oct 15, 1999 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K980380 | NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS | Jul 14, 1999 | Substantially Equivalent | DIAMETRICS MEDICAL, LTD. |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | Jul 09, 1999 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K983799 | MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL | Jan 26, 1999 | Substantially Equivalent | MEDTRONIC PS MEDICAL |
| K982702 | VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD | Sep 10, 1998 | Substantially Equivalent | CAMINO NEUROCARE, INC. |
| K981846 | PARENCHYMAL BOLT PRESSURE MONITORING KIT | Aug 18, 1998 | Substantially Equivalent | CAMINO NEUROCARE, INC. |
| K974088 | CODMAN INTRACRANIAL BOLT | Jan 09, 1998 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K962928 | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) | Dec 20, 1996 | Substantially Equivalent | CAMINO NEUROCARE, INC. |
| K945585 | COMAN(R) CU-11 MODEL NUMBER 82-6634 | Oct 26, 1995 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K931609 | CHARTR ENG SYSTEM | Sep 26, 1995 | Substantially Equivalent | ICS MEDICAL CORP. |
| K940648 | CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER | Mar 01, 1995 | Substantially Equivalent | CORDIS CORP. |
| K943987 | OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE | Dec 07, 1994 | Substantially Equivalent | INNERSPACE MEDICAL, INC. |
| K914479 | MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER | Mar 07, 1994 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K930221 | CAMINO VENTRICULAR TRANSDUCER ACCESSORY | Apr 15, 1993 | Substantially Equivalent | CAMINO LABORATORIES, INC. |
| K912139 | MODEL 704 | Mar 25, 1992 | Substantially Equivalent | IVY BIOMEDICAL SYSTEMS, INC. |
| K914735 | VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM | Jan 17, 1992 | Substantially Equivalent | CAMINO LABORATORIES, INC. |
| K884823 | TRANSPAC(R) II, DISPOSABLE TRANSDUCER | Jul 03, 1990 | Substantially Equivalent | ABBOTT LABORATORIES |
| K896834 | MODEL BT-1 FOT BOLT INSTALLATION KIT | Feb 23, 1990 | Substantially Equivalent | PEARL INSTRUMENTS CORP. |
| K893395 | MINI-MONITOR J7000 ICP | Nov 22, 1989 | Substantially Equivalent | LADD RESEARCH INDUSTRIES, INC. |
| K890468 | MODEL FT-100 INTRACRANIAL PRESSURE MONITOR | Apr 26, 1989 | Substantially Equivalent | PEARL INSTRUMENTS CORP. |
| K883881 | MODIFIED MODEL 2001 FIBER OPTICS CATHETER | Oct 27, 1988 | Substantially Equivalent | METATECH CORP. |
| K883518 | EVENT MARKER & A SECOND PRESSURE TREND OUTPUT | Sep 22, 1988 | Substantially Equivalent | METATECH CORP. |
| K882552 | METATECH ROBINSON BOLT ACCESSORY | Sep 08, 1988 | Substantially Equivalent | METATECH CORP. |
| K883115 | PMT SUBARACHNOID SCREW, MODEL NO.1350-2 | Aug 29, 1988 | Substantially Equivalent | PMT CORP. |
| K882286 | EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET | Jul 18, 1988 | Substantially Equivalent | METATECH CORP. |
| K881183 | VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H | May 04, 1988 | Substantially Equivalent | CAMINO LABORATORIES, INC. |
| K880154 | METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM | Mar 28, 1988 | Substantially Equivalent | METATECH CORP. |
| K862820 | LADD/STERITEK ICP MONITOR, CAT. NO. P3000 | Feb 26, 1987 | Substantially Equivalent | LADD RESEARCH INDUSTRIES, INC. |
| K863479 | MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL | Oct 14, 1986 | Substantially Equivalent | MEDICAL MEASUREMENTS, INC. |
| K853770 | CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT | Oct 06, 1986 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K862012 | LADD MEDICAL S-2000 | Jun 09, 1986 | Substantially Equivalent | LADD RESEARCH INDUSTRIES, INC. |
| K853864 | INTRACRANIAL PRESSURE MONITORING KIT 070 | Feb 20, 1986 | Substantially Equivalent | CAMINO LABORATORIES, INC. |
| K854657 | INTRACRANIAL PRESSURE MONITORING CUP CATHETERS | Dec 27, 1985 | Substantially Equivalent | CORDIS CORP. |
| K844566 | ICP MONITOR MODEL 1000 | Aug 16, 1985 | Substantially Equivalent | ADVANCED ULTRASONIC TESTING & RESEARCH CORP. |
| K840999 | PHILLY INFANT BOLT | Apr 04, 1984 | Substantially Equivalent | PHILADELPHIA MEDICAL SPECIALTIES |
| K840003 | DISPOSABLE ICP KIT DIFF. SIZES | Feb 28, 1984 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K822864 | INTRACRANIAL PRESSURE MONITORING DEVICE | Nov 16, 1982 | Substantially Equivalent | MEDEX, INC. |
| K822636 | CLASS II DEVICE FOR I.C.P. MONITORING | Sep 14, 1982 | Substantially Equivalent | PHILADELPHIA MEDICAL SPECIALTIES |
| K813440 | PHILLY BOLT | Dec 18, 1981 | Substantially Equivalent | PHILADELPHIA MEDICAL SPECIALTIES |
| K802149 | TM-5 INTRACRANIAL PRESSURE MONITOR | Nov 12, 1980 | Substantially Equivalent | NICOLET BIOMEDICAL INSTRUMENTS |
| K802138 | CHEEK TOOL SET | Oct 31, 1980 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K802137 | CHEEK EPIDURAL SCREW | Oct 31, 1980 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K802100 | INTRACRANIAL PRESSURING MONITORING SYST. | Sep 16, 1980 | Substantially Equivalent | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
| K801755 | MMI/GAELTEC CATHETER TIP PRESSURE | Aug 13, 1980 | Substantially Equivalent | MEDICAL MEASUREMENTS, INC. |
| K790920 | INTRACRANIAL PRESSURE MONITORING | Aug 03, 1979 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K772063 | CATHETER, INTRACRANIAL PRESS. MONITOR. | Jan 03, 1978 | Substantially Equivalent | CORDIS CORP. |
FEI Numbers
This FDA classification entry is associated with 63 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.