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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 a medical device manufactured by St Jude Medical. It received FDA 510(k) clearance on 2018-07-20 under approval 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. It is manufactured by St Jude Medical. The 510(k) number is K181382.

When was GuardianTM Burr Hole Cover System approved by the FDA?

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

What company makes GuardianTM Burr Hole Cover System?

GuardianTM Burr Hole Cover System is manufactured by St Jude Medical.

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)

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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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