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

    MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM

    K Number: K973584 · Decision Jan 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    58
    Applicant Total
    2
    Review Days
    109

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    Basic Information

    Device Name
    MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM
    K Number
    K973584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtech Instruments
    Date Received
    September 22, 1997
    Decision Date
    January 9, 1998
    Product Code
    ESW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ESW Prosthesis, Esophageal

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    Other Clearances by Medtech Instruments

    K Number Device Name
    K894772 THERMALGRAPHIC ANALYSER