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FDA 510(k)

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

K-Number: K200723 · 2020-06-26

ApplicantMedtronic Navigation, Inc.
Decision Date2020-06-26
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2020-06-26 under approval number K200723. 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 StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K200723.

When was StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) approved by the FDA?

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) received FDA 510(k) clearance on 2020-06-26, under approval number K200723.

What company makes StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

The FDA product code for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is PGW.

Other Devices by Medtronic Navigation, Inc.

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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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