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FDA 510(k)

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

K-Number: K232890 · 2024-02-04

ApplicantIntegra Lifesciences Production Corporation
Decision Date2024-02-04
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2024-02-04 under 510(k) number K232890. 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 (826820), CereLink ICP Extension Cable (826845)?

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) is a medical device that received FDA 510(k) clearance on 2024-02-04. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K232890.

When did CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) receive FDA 510(k) clearance?

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) received FDA 510(k) clearance on 2024-02-04, under 510(k) number K232890.

Who is the listed applicant for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)?

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

What is the FDA product code for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)?

The FDA product code for CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) is GWM.

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Related Devices (Code: GWM)

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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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