FDA 510(k)

LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT

K-Number: K053244 · 2006-05-10

Decision Date2006-05-10

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2006-05-10 under 510(k) number K053244. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT?

LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT is a medical device that received FDA 510(k) clearance on 2006-05-10. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K053244.

When did LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT receive FDA 510(k) clearance?

LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT received FDA 510(k) clearance on 2006-05-10, under 510(k) number K053244.

Who is the listed applicant for LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT?

The FDA product code for LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT is GWM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Integra Lifesciences Corp. as applicant

K183581Codman Disposable Perforators K183406CereLink ICP Monitor, CereLink ICP Extension Cable K182265CodMan Certas Plus Programmable Valve K181902Codman Certas Plus Electronic Tool Kit K131184INTEGRA LICOX PTO2 MONITOR K092227JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS

View all 27 devices →

Related Devices (Code: GWM)

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa 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 AG K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.