BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MICROGUIDE LESION MARKING SYSTEM

    K Number: K923120 · Decision Sep 1, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    236
    Registration Numbers
    236
    Same Product Code
    27
    Applicant Total
    6
    Review Days
    67

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    Basic Information

    Device Name
    MICROGUIDE LESION MARKING SYSTEM
    K Number
    K923120
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Angiodynamics, Div. E-Z-Em, Inc.
    Date Received
    June 26, 1992
    Decision Date
    September 1, 1992
    Product Code
    GDF
    Advisory Committee
    General, Plastic Surgery
    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
    GDF Guide, Needle, Surgical

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