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

    ENDOMETRIAL PIPELLE

    K Number: K854415 · Decision Mar 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    41
    Applicant Total
    10
    Review Days
    129

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    Basic Information

    Device Name
    ENDOMETRIAL PIPELLE
    K Number
    K854415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1175
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Unimar, Inc.
    Date Received
    November 4, 1985
    Decision Date
    March 13, 1986
    Product Code
    HHK
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HHK Curette, Suction, Endometrial (And Accessories)

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