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FDA 510(k)

StealthStation Cranial Software, v3.1.5 (9735585)

K-Number: K231976 · 2023-10-19

ApplicantMedtronic Navigation, Inc.
Decision Date2023-10-19
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStation Cranial Software, v3.1.5 (9735585) is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2023-10-19 under approval number K231976. 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, v3.1.5 (9735585)?

StealthStation Cranial Software, v3.1.5 (9735585) is a medical device that received FDA 510(k) clearance on 2023-10-19. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K231976.

When was StealthStation Cranial Software, v3.1.5 (9735585) approved by the FDA?

StealthStation Cranial Software, v3.1.5 (9735585) received FDA 510(k) clearance on 2023-10-19, under approval number K231976.

What company makes StealthStation Cranial Software, v3.1.5 (9735585)?

StealthStation Cranial Software, v3.1.5 (9735585) is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for StealthStation Cranial Software, v3.1.5 (9735585)?

The FDA product code for StealthStation Cranial Software, v3.1.5 (9735585) 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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