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

    CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM

    K Number: K022126 · Decision Jan 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    12
    Review Days
    186

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
    K Number
    K022126
    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
    July 1, 2002
    Decision Date
    January 3, 2003
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HAW), ordered by most recent decision date.

    Zeta Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stealth AXiS Cranial clinical application

    FDA 510(k)
    FDA Class 2 ·Neurology

    NeuroAlign software

    FDA 510(k)
    FDA Class 2 ·Neurology

    SOLOPASS 2.0 System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ball Joint Guide Array (66295)

    FDA 510(k)
    FDA Class 2 ·Neurology

    EZ-FIDUCIALS

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Medtronic Surgical Navigation Technologies

    K Number Device Name
    K050438 STEALTHSTATION SYSTEM UPDATE
    K043088 MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
    K030552 IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
    K030106 STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
    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
    K002869 LOCALISA CARDIAC NAVIGATION SYSTEM
    K003201 STEALTHSTATION TREATMENT GUIDANCE PLATFORM
    Search all 12 clearances from Medtronic Surgical Navigation Technologies →