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

    READYCATH CATHETER

    K Number: K973120 · Decision Feb 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    12
    Review Days
    189

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    Basic Information

    Device Name
    READYCATH CATHETER
    K Number
    K973120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Technologies of Georgia
    Date Received
    August 20, 1997
    Decision Date
    February 25, 1998
    Product Code
    GBM
    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
    GBM Catheter, Urethral

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