FDA.report

510(k) K232890

Device
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
Applicant
Integra Lifesciences Production Corporation
510(k) number
K232890
Product code
GWM
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-04
Date received
2023-09-18
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

Related Records

Applicant Contact

Contact
Kali Sacco
Address
11 Cabot Blvd. Mansfield MA US 02048 02048

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code GWM

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
K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.2024-07-18
K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.2021-10-08
K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation2021-04-30
K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser LevelMedtronic, Inc.2020-05-26
K200630Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage BagsMedtronic, Inc.2020-04-09
K200456Becker External Drainage and Monitoring SystemMedtronic, Inc.2020-03-26
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
K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc.2016-10-20