Cleared Traditional

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

K232890 · Integra Lifesciences Production Corporation · Neurology
Feb 2024
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K232890 is an FDA 510(k) clearance for the CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845), a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Integra Lifesciences Production Corporation (Mansfield, US). The FDA issued a Cleared decision on February 4, 2024, 139 days after receiving the submission on September 18, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K232890 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2023
Decision Date February 04, 2024
Days to Decision 139 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWM — Device, Monitoring, Intracranial Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1620

Similar Devices — GWM Device, Monitoring, Intracranial Pressure

All 103
NEUROVENT-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); BOL
K250285 · Raumedic AG · Aug 2025
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K240821 · Braincare Desenvolvimento E Inova??o Tecnol?gica S.A. · Jul 2024
B4C System
K201989 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 2021
CereLink ICP Monitor
K210993 · Integra Lifesciences Production Corporation · Apr 2021
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
K201118 · Medtronic, Inc. · May 2020
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
K200630 · Medtronic, Inc. · Apr 2020

More from Integra Lifesciences...

View all
Codman Libert?s Shunt Catheter with Bactiseal and Endexo Technology
K243531 · JXG · Aug 2025
Codman Libert?s? 1.5 mm EVD Catheter with Bactiseal? and Endexo? Technology with Luer Connection (821761); Codman Libert?s? 1.9 mm EVD Catheter with Bactiseal? and Endexo? Technology with Luer Connection (821762)
K243552 · JXG · Aug 2025
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
K233445 · JXG · Jan 2024
Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
K233448 · JXG · Dec 2023
Certas Plus Programmable Valves
K223330 · JXG · Feb 2023