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FDA 510(k)

StealthStation Cranial Software v1.3.0

K-Number: K201175 · 2020-06-03

ApplicantMedtronic Navigation, Inc.
Decision Date2020-06-03
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStation Cranial Software v1.3.0 is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2020-06-03 under approval number K201175. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StealthStation Cranial Software v1.3.0?

StealthStation Cranial Software v1.3.0 is a medical device that received FDA 510(k) clearance on 2020-06-03. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K201175.

When was StealthStation Cranial Software v1.3.0 approved by the FDA?

StealthStation Cranial Software v1.3.0 received FDA 510(k) clearance on 2020-06-03, under approval number K201175.

What company makes StealthStation Cranial Software v1.3.0?

StealthStation Cranial Software v1.3.0 is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for StealthStation Cranial Software v1.3.0?

The FDA product code for StealthStation Cranial Software v1.3.0 is HAW.

Other Devices by Medtronic Navigation, Inc.

K162604Cranial Reducing Tubes K153660StealthStation System with Cranial Software K153555EM ENT Navigated Suctions K153247Fusion Compact Navigation System K170018StealthStationTM S8 ENT Software K162655StealthConnect Remote Viewing, Planning and Collaboration System

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Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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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