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

    INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS

    K Number: K941487 · Decision Feb 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    58
    Applicant Total
    4
    Review Days
    332

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    Basic Information

    Device Name
    INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS
    K Number
    K941487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Instent, Inc.
    Date Received
    March 28, 1994
    Decision Date
    February 23, 1995
    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 Instent, Inc.

    K Number Device Name
    K955041 INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM
    K945498 INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS
    K924387 INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS