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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

DateFirm and productCodeLinked 510(k)
Jan 8, 2026Integra LifeSciences Corp. (NeuroSciences)
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The I
Open, Classified
GWMK173192
Jan 8, 2026Integra LifeSciences Corp. (NeuroSciences)
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and
Open, Classified
GWMK153347
Jan 8, 2026Sophysa
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Open, Classified
GWMK162108
Dec 19, 2024Medtronic Neurosurgery
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/
Open, Classified
GWMK200456
Dec 19, 2024Medtronic Neurosurgery
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 276
Open, Classified
GWMK200456
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
Open, Classified
GWMK020780
Oct 23, 2024Smiths Medical ASD, Inc.
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Open, Classified
GWMK020780
May 15, 2024Sophysa S.A.
The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use
Open, Classified
GWMK062584
K162108
May 15, 2024Sophysa S.A.
The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricul
Open, Classified
GWMK062584
K162108
Dec 14, 2023Integra LifeSciences Corp.
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part o
Open, Classified
GWMK210993
K232890
May 19, 2023Integra LifeSciences Corp.
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607
Open, Classified
GWMK914479
Jul 22, 2022Integra LifeSciences Corp.
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Open, Classified
GWMK210993
Sep 12, 2019Integra LifeSciences Corp.
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Open, Classified
GWMK183406
Jun 18, 2015Integra LifeSciences Corp.
Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure mo
Terminated
GWMK102875
May 15, 2015Integra LifeSciences Corp.
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displ
Terminated
GWMK121573
K131184
May 15, 2015Integra LifeSciences Corp.
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displa
Terminated
GWMK121573
K131184
May 15, 2015Integra LifeSciences Corp.
The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displa
Terminated
GWMK121573
K131184
Dec 18, 2014Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX Complete Brain Probe Kit (comprised of
Terminated
GWMK002765
K040235 +1
Nov 10, 2014Integra LifeSciences Corp.
Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeScien
Terminated
GWMK131184
May 30, 2014Integra LifeSciences Corp.
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibrati
Terminated
GWMK131184
Dec 27, 2013Integra LifeSciences Corp.
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use w
Terminated
GWMK962928
Oct 30, 2013Integra Limited
Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-
Terminated
GWMK102875
Oct 23, 2013Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Ge
Terminated
GWMK040235
Oct 23, 2013Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Ger
Terminated
GWMK040235
Oct 23, 2013Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Ge
Terminated
GWMK040235
Oct 23, 2013Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germa
Terminated
GWMK040235
Oct 23, 2013Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germa
Terminated
GWMK040235
Oct 23, 2013Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germ
Terminated
GWMNone listed
Oct 23, 2013Integra LifeSciences Corp.
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf,
Terminated
GWMK040235
Oct 23, 2013Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany
Terminated
GWMK040235
Oct 23, 2013Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany
Terminated
GWMK040235
Oct 23, 2013Integra LifeSciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany
Terminated
GWMK040235
Mar 22, 2012Codman & Shurtleff, Inc.
Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, inclu
Terminated
GWMK974088
Feb 3, 2012Integra LifeSciences Corp
Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors
Terminated
GWMK962928
Jan 11, 2012Codman & Shurtleff, Inc.
Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw, Pediatric Product Code:80-1197 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits whic
Terminated
GWMK853770
Jan 11, 2012Codman & Shurtleff, Inc.
Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult Product Code:80-1196 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which pr
Terminated
GWMK853770
Jan 11, 2012Codman & Shurtleff, Inc.
Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid Screw Product Code:80-1190 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which pr
Terminated
GWMK853770
Jan 11, 2012Codman & Shurtleff, Inc.
Codman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) t
Terminated
GWMK914479
Jan 11, 2012Codman & Shurtleff, Inc.
Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow ph
Terminated
GWMK914479
Apr 20, 2011Codman & Shurtleff, Inc.
Codman Plastic Disposable ICP Kit, Complete, Adult Product Code 80-1197 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedu
Terminated
GWMNone listed
Apr 20, 2011Codman & Shurtleff, Inc.
Codman Cranial Hand Drill Product Code: 82-6607 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
Terminated
GWMNone listed
Apr 20, 2011Codman & Shurtleff, Inc.
Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
Terminated
GWMK853770
Apr 20, 2011Codman & Shurtleff, Inc.
Codman Metal Disposable ICP Kit Product Code: 80-1190 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
Terminated
GWMNone listed
Apr 20, 2011Codman & Shurtleff, Inc.
Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
Terminated
GWMK853770
Apr 20, 2011Codman & Shurtleff, Inc.
Codman Disposable Twist Drill Product code: 80-1200 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
Terminated
GWMNone listed
Mar 3, 2011Integra LifeSciences Corp.
LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf, Germany; Distributed by Integra NeuroSc
Terminated
GWMK002765
Oct 28, 2010Integra LifeSciences Corp.
Licox Brain PMO Probe Kit; Ref IP2.P; Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe; Contains st
Terminated
GWMK040235
Apr 20, 2010Integra LifeSciences Corp.
Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if pa
Terminated
GWMK040235
Dec 29, 2009Spiegelberg Gmbh & Co. KG
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracr
Terminated
GWMK003759
Aug 5, 2008Integra Neuro Sciences
INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences
Terminated
GWMK071505

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