FDA 510(k)

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

K-Number: K153041 · 2016-03-14

ApplicantIntegra LifeSciences Corporation

Decision Date2016-03-14

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2016-03-14 under 510(k) number K153041. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling?

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is a medical device that received FDA 510(k) clearance on 2016-03-14. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K153041.

When did Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling receive FDA 510(k) clearance?

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling received FDA 510(k) clearance on 2016-03-14, under 510(k) number K153041.

Who is the listed applicant for Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling?

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

What is the FDA product code for Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling?

The FDA product code for Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is JXG.

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Official Source

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