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

    DISPOSABLE PNEUMOPERITONEUM NEEDLE

    K Number: K863330 · Decision Oct 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    14
    Applicant Total
    218
    Review Days
    44

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    Basic Information

    Device Name
    DISPOSABLE PNEUMOPERITONEUM NEEDLE
    K Number
    K863330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    August 19, 1986
    Decision Date
    October 2, 1986
    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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