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GWM — Device, Monitoring, Intracranial Pressure Class II

FDA Device Classification

Classification Details

Product Code
GWM
Device Class
Class II
Regulation Number
882.1620
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250285raumedicNEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); August 29, 2025
K240821braincare desenvolvimento e inovação tecnológicaB4C System - Addition of new sensor model (BcSs-PICNIW-2000)July 18, 2024
K232890integra lifesciences production corporationCereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)February 4, 2024
K201989braincare desenvolvimento e inovacao tecnologicaB4C SystemOctober 8, 2021
K210993integra lifesciences production corporationCereLink ICP MonitorApril 30, 2021
K201118medtronicExacta External Drainage and Monitoring System, Exacta Pole with Laser Level, ExMay 26, 2020
K200630medtronicMedtronic External Drainage and Monitoring System, Medtronic External Drainage aApril 9, 2020
K200456medtronicBecker External Drainage and Monitoring SystemMarch 26, 2020
K182073braincare desenvolvimento e inovacao tecnologicaBcSs-PICNI-2000 SensorOctober 17, 2019
K183406integra lifesciencesCereLink ICP Monitor, CereLink ICP Extension CableJanuary 11, 2019
K172209branchpoint technologiesAURA ICP MONITORING SYSTEMMay 18, 2018
K173192codman and shurtleffCereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLinNovember 8, 2017
K171666raumedicMPR2 logO DATALOGGERJuly 6, 2017
K162108sophysaPressio 2 ICP Monitoring SystemApril 17, 2017
K161010innerspace neuro solutionsHICP200 Patient/Monitor Interconnect CableOctober 20, 2016
K153347codman and shurtleffCodman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman August 19, 2016
K152670medos international sarlDirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor InterfaceJanuary 22, 2016
K141869hemedex incorporatedQFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KITOctober 10, 2014
K133754integra lifesciences corporationINTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX AMarch 6, 2014
K130529raumedicRAUMEDIC-PTO-MONITORING-SYSTEMOctober 25, 2013