Cleared Special

K053244 - LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
(FDA 510(k) Clearance)

K053244 · Integra Lifesciences Corp. · Neurology
May 2006
Decision
170d
Days
Class 2
Risk

K053244 is an FDA 510(k) clearance for the LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on May 10, 2006, 170 days after receiving the submission on November 21, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K053244 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2005
Decision Date May 10, 2006
Days to Decision 170 days
Submission Type Special
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
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890 · Integra Lifesciences Production Corporation · Feb 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