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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) 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. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K200723.

When did StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) receive FDA 510(k) clearance?

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

Who is the listed applicant for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Medtronic Navigation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253379Stealth AXiS Cranial clinical applicationK253395Stealth AXiS™ ENT clinical applicationK253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationK251282StealthStation S8 Spine SoftwareK242464Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

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Related Devices (Code: PGW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbHK253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavK231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.K223734ENT EMBrainlab AGK221037TruDi Shaver BladeAcclarent, 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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