GWM · Class II · 21 CFR 882.1620

FDA Product Code GWM: Device, Monitoring, Intracranial Pressure

Leading manufacturers include Codman & Shurtleff, Inc., Integra LifeSciences Corporation and Johnson & Johnson Professionals, Inc..

105
Total
105
Cleared
149d
Avg days
1978
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 239d recently vs 147d historically

FDA 510(k) Cleared Device, Monitoring, Intracranial Pressure Devices (Product Code GWM)

105 devices
1–24 of 105
Cleared Apr 10, 2026
Pressio 3 Multi-parameter Neuromonitoring System
K252241
Sophysa
Neurology · 267d
Cleared Aug 29, 2025
NEUROVENT-P (092946-003)
K250285
Raumedic AG
Neurology · 210d
Cleared Jul 18, 2024
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K240821
Braincare Desenvolvimento E Inova??o Tecnol?gica S.A.
Neurology · 115d
Cleared Feb 04, 2024
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890
Integra Lifesciences Production Corporation
Neurology · 139d
Cleared Oct 08, 2021
B4C System
K201989
Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Neurology · 448d
Cleared Apr 30, 2021
CereLink ICP Monitor
K210993
Integra Lifesciences Production Corporation
Neurology · 28d
Cleared May 26, 2020
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
K201118
Medtronic, Inc.
Neurology · 29d
Cleared Apr 09, 2020
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
K200630
Medtronic, Inc.
Neurology · 30d
Cleared Mar 26, 2020
Becker External Drainage and Monitoring System
K200456
Medtronic, Inc.
Neurology · 30d
Cleared Oct 17, 2019
BcSs-PICNI-2000 Sensor
K182073
Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Neurology · 442d
Cleared Jan 11, 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406
Integra Lifesciences Corp.
Neurology · 32d
Cleared May 18, 2018
AURA ICP MONITORING SYSTEM
K172209
Branchpoint Technologies, Inc.
Neurology · 298d
Cleared Nov 08, 2017
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
K173192
Codman & Shurtleff, Inc.
Neurology · 37d
Cleared Aug 19, 2016
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
K153347
Codman & Shurtleff, Inc.
Neurology · 273d
Cleared Jan 22, 2016
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
K152670
Medos International SARL
Neurology · 127d
Cleared Mar 06, 2014
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
K133754
Integra LifeSciences Corporation
Neurology · 87d
Cleared Dec 20, 2010
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875
Integra LifeSciences Corporation
Neurology · 80d
Cleared Aug 06, 2007
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K071505
Integra LifeSciences Corporation
Neurology · 66d
Cleared Jul 27, 2006
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K061640
Integra LifeSciences Corporation
Neurology · 45d
Cleared Apr 20, 2004
LICOX PMO BRAIN MONITORING SYSTEM
K040235
Integra LifeSciences Corporation
Neurology · 78d
Cleared May 20, 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780
Medex, Inc.
Neurology · 70d
Cleared Jun 28, 2001
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759
Aesculap, Inc.
Neurology · 204d
Cleared Oct 15, 1999
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591
Codman & Shurtleff, Inc.
Neurology · 74d
Cleared Jul 09, 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222
Johnson & Johnson Professionals, Inc.
Neurology · 88d

About Product Code GWM - Regulatory Context

510(k) Submission Activity

105 total 510(k) submissions under product code GWM since 1978, with 105 receiving FDA clearance (average review time: 149 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - GWM Product Code

Recent submissions under GWM have taken an average of 239 days to reach a decision - up from 147 days historically. Manufacturers should account for longer review timelines in current project planning.

GWM devices are reviewed by the Neurology panel. Browse all Neurology devices →