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FDA 510(k)

StealthStationTM S8 ENT Software

K-Number: K170018 · 2017-05-19

ApplicantMedtronic Navigation, Inc.
Decision Date2017-05-19
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStationTM S8 ENT Software is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2017-05-19 under approval number K170018. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StealthStationTM S8 ENT Software?

StealthStationTM S8 ENT Software is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K170018.

When was StealthStationTM S8 ENT Software approved by the FDA?

StealthStationTM S8 ENT Software received FDA 510(k) clearance on 2017-05-19, under approval number K170018.

What company makes StealthStationTM S8 ENT Software?

StealthStationTM S8 ENT Software is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for StealthStationTM S8 ENT Software?

The FDA product code for StealthStationTM S8 ENT Software is PGW.

Other Devices by Medtronic Navigation, Inc.

K162604Cranial Reducing Tubes K153660StealthStation System with Cranial Software K153555EM ENT Navigated Suctions K153247Fusion Compact Navigation System K162655StealthConnect Remote Viewing, Planning and Collaboration System K162309StealthStation S8 System Platforms and StealthStation Cranial Software

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Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. K161701CARTO ENT SystemBiosense Webster K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. K161940Guidewire 0.6 Single UseFiagon GmbH K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc.

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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