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

    MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4

    K Number: K853216 · Decision Apr 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    41
    Applicant Total
    5
    Review Days
    244

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    Basic Information

    Device Name
    MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4
    K Number
    K853216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1175
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Gyneco, Inc.
    Date Received
    August 1, 1985
    Decision Date
    April 2, 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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    Other Clearances by Gyneco, Inc.

    K Number Device Name
    K861409 SYNCARE TEMPORARY CARDIAC PACING WIRE
    K852357 GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP
    K843941 ENDOCYTE
    K841275 FINE NEEDLE ASPIRATION DEVICE