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

    FLEX FINDER GUIDEWIRE

    K Number: K923755 · Decision Sep 3, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    406

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    Basic Information

    Device Name
    FLEX FINDER GUIDEWIRE
    K Number
    K923755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Flex Medics Corporation
    Date Received
    July 24, 1992
    Decision Date
    September 3, 1993
    Product Code
    OCY
    Advisory Committee
    Gastroenterology, Urology
    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
    OCY Endoscopic Guidewire, Gastroenterology-Urology

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