FDA 510(k)

CereLink ICP Monitor, CereLink ICP Extension Cable

K-Number: K183406 · 2019-01-11

Decision Date2019-01-11

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CereLink ICP Monitor, CereLink ICP Extension Cable 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 2019-01-11 under 510(k) 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. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K183406.

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

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

Who is the listed applicant for CereLink ICP Monitor, CereLink ICP Extension Cable?

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 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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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.