FDA.report

510(k) K253395

Device
Stealth AXiS™ ENT clinical application
Applicant
Medtronic Navigation, Inc.
510(k) number
K253395
Product code
PGW
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-16
Date received
2025-09-30
Regulation
882.4560
Classification name
Ear, Nose, And Throat Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Victoria Baldock
Address
200 Medtronic Dr. Lafayette CO US 80026 80026

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code PGW

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K223734ENT EMBrainlab AG2023-04-27
K221037TruDi Shaver BladeAcclarent, Inc.2022-07-20
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K202609Instrument Clamps ElectromagneticStryker Corporation2020-10-09
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K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)Medtronic Navigation, Inc.2020-06-26
K193453TruDi ProbeAcclarent, Inc.2020-03-23
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K193118TGS Guidewire and updated Scopis SoftwareStryker Ent2020-02-21
K193502TGS Universal Headrest with Mounting ArmStryker Ent2020-02-14
K192397TruDi Navigation SystemBiosense Webster2020-01-30
K190532TruDi NAV WireAcclarent, Inc.2019-05-03