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

    SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER

    K Number: K891290 · Decision May 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    43
    Review Days
    74

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    Basic Information

    Device Name
    SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
    K Number
    K891290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Cook Ob/Gyn
    Date Received
    March 10, 1989
    Decision Date
    May 23, 1989
    Product Code
    HES
    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
    HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

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    Other Clearances by Cook Ob/Gyn

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    K030441 SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
    K023850 SYDNEY IVF EMBRYO BIOPSY MEDIUM
    K013597 TAMPONADE UTERINE BALLOON CATHETER SET
    K002385 COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
    K002383 COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
    K983595 TRANSMYOMETRIAL EMBRYO TRANSFER SET
    K983596 INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
    K983642 COOK MINI-INCUBATOR
    K983593 OVUM PICK-UP ASPIRATION NEEDLES
    Search all 43 clearances from Cook Ob/Gyn →