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

    PEANUT WAND, MODIFICATION

    K Number: K944067 · Decision Dec 8, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    16
    Review Days
    135

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    Basic Information

    Device Name
    PEANUT WAND, MODIFICATION
    K Number
    K944067
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ideal Medical, Inc.
    Date Received
    July 26, 1994
    Decision Date
    December 8, 1994
    Product Code
    GCS
    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
    GCS Endoscope, Battery-Powered And Accessories

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