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FDA 510(k)

CereLink ICP Monitor, CereLink ICP Extension Cable

K-Number: K183406 · 2019-01-11

ApplicantIntegra Lifesciences Corp.
Decision Date2019-01-11
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CereLink ICP Monitor, CereLink ICP Extension Cable is a medical device manufactured by Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2019-01-11 under approval number K183406. 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 CereLink ICP Monitor, CereLink ICP Extension Cable?

CereLink ICP Monitor, CereLink ICP Extension Cable is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Integra Lifesciences Corp.. The 510(k) number is K183406.

When was CereLink ICP Monitor, CereLink ICP Extension Cable approved by the FDA?

CereLink ICP Monitor, CereLink ICP Extension Cable received FDA 510(k) clearance on 2019-01-11, under approval number K183406.

What company makes CereLink ICP Monitor, CereLink ICP Extension Cable?

CereLink ICP Monitor, CereLink ICP Extension Cable is manufactured by Integra Lifesciences Corp..

What is the FDA product code for CereLink ICP Monitor, CereLink ICP Extension Cable?

The FDA product code for CereLink ICP Monitor, CereLink ICP Extension Cable is GWM.

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Related Devices (Code: GWM)

K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitCodman & Shurtleff, Inc. K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesMedos International SARL 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. K171666MPR2 logO DATALOGGERRaumedic AG K162108Pressio 2 ICP Monitoring SystemSophysa SA

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.

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