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

    PNEUMO-MATIC INSUFFLATION NEEDLE

    K Number: K970788 · Decision Mar 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    14
    Applicant Total
    9
    Review Days
    23

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    Basic Information

    Device Name
    PNEUMO-MATIC INSUFFLATION NEEDLE
    K Number
    K970788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apple Medical Corp.
    Date Received
    March 4, 1997
    Decision Date
    March 27, 1997
    Product Code
    FHO
    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
    FHO Pneumoperitoneum Needle

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