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

    STEALTHSTATION TREATMENT GUIDANCE PLATFORM

    K Number: K003201 · Decision Dec 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    12
    Review Days
    61

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    Basic Information

    Device Name
    STEALTHSTATION TREATMENT GUIDANCE PLATFORM
    K Number
    K003201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Surgical Navigation Technologies
    Date Received
    October 12, 2000
    Decision Date
    December 12, 2000
    Product Code
    HAW
    Advisory Committee
    Neurology
    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
    HAW Neurological Stereotaxic Instrument

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    Other Clearances by Medtronic Surgical Navigation Technologies

    K Number Device Name
    K050438 STEALTHSTATION SYSTEM UPDATE
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    K030552 IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
    K030106 STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
    K022126 CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
    K021980 HIP MODULE FOR THE STEALTHSTATION SYSTEM
    K022414 STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
    K020338 STEALTHSTATION WITH FLUOROMERGE SOFTWARE
    K012937 KNEE MODULE FOR THE STEALTHSTATION SYSTEM
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