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FDA 510(k)

GuardianTM Burr Hole Cover System

K-Number: K181382 · 2018-07-20

ApplicantSt Jude Medical
Decision Date2018-07-20
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GuardianTM Burr Hole Cover System is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K181382. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GuardianTM Burr Hole Cover System?

GuardianTM Burr Hole Cover System is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is St Jude Medical. The 510(k) number is K181382.

When did GuardianTM Burr Hole Cover System receive FDA 510(k) clearance?

GuardianTM Burr Hole Cover System received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181382.

Who is the listed applicant for GuardianTM Burr Hole Cover System?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GuardianTM Burr Hole Cover System?

The FDA product code for GuardianTM Burr Hole Cover System is GXR.

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Related Devices (Code: GXR)

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.

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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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