FDA.reportPublic FDA data

510(k) K002765

Device
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
Applicant
Integra Neurosciences
510(k) number
K002765
Product code
GWM
Decision
Substantially Equivalent (SESE)
Decision date
2000-11-24
Date received
2000-09-05
Regulation
882.1620
Classification name
Device, Monitoring, Intracranial Pressure
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
NANCY MATHEWSON
Address
5955 Pacific Center Blvd. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GWM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa2026-04-10
K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AG2025-08-29
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K182073BcSs-PICNI-2000 SensorBraincare Desenvolvimento E Inovacao Tecnologica S.A.2019-10-17
K183406CereLink ICP Monitor, CereLink ICP Extension CableIntegra Lifesciences Corp.2019-01-11
K172209AURA ICP MONITORING SYSTEMBranchpoint Technologies, Inc.2018-05-18
K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitCodman & Shurtleff, Inc.2017-11-08
K171666MPR2 logO DATALOGGERRaumedic AG2017-07-06
K162108Pressio 2 ICP Monitoring SystemSophysa SA2017-04-17