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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K253395
Device Name Stealth AXiS™ ENT clinical application
Applicant
Medtronic Navigation, Inc.
200 Medtronic Dr.
Lafayette,  CO  80026
Applicant Contact Victoria Baldock
Correspondent
Medtronic Navigation, Inc.
200 Medtronic Dr.
Lafayette,  CO  80026
Correspondent Contact Maulik Shah
Regulation Number882.4560
Classification Product Code
PGW  
Date Received09/30/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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