BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Visualase MRI-Guided Laser Ablation System (SW 3.4)

    K Number: K211269 · Decision Jan 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    35
    Review Days
    255

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    Basic Information

    Device Name
    Visualase MRI-Guided Laser Ablation System (SW 3.4)
    K Number
    K211269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Navigation, Inc.
    Date Received
    April 27, 2021
    Decision Date
    January 7, 2022
    Product Code
    ONO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ONO Neurosurgical Laser With Mr Thermography

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    Other Clearances by Medtronic Navigation, Inc.

    K Number Device Name
    K253379 Stealth AXiS Cranial clinical application
    K253395 Stealth AXiS™ ENT clinical application
    K253391 Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
    K253381 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
    K251282 StealthStation S8 Spine Software
    K242464 Stealth™ Spine Clamps; ModuLeX™ Shank Mounts
    K240465 O-arm O2 Imaging System
    K231976 StealthStation Cranial Software, v3.1.5 (9735585)
    K221087 Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
    K203639 StealthStation Cranial Software v1.3.2
    Search all 35 clearances from Medtronic Navigation, Inc. →