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

    GLEESON CLOT-BUSTER

    K Number: K920139 · Decision Apr 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    13
    Applicant Total
    92
    Review Days
    93

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    Basic Information

    Device Name
    GLEESON CLOT-BUSTER
    K Number
    K920139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Conmedcorp
    Date Received
    January 13, 1992
    Decision Date
    April 15, 1992
    Product Code
    GCI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCI Laryngoscope, Endoscope

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