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

    ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION

    K Number: K940176 · Decision Apr 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    28
    Applicant Total
    42
    Review Days
    833

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    Basic Information

    Device Name
    ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
    K Number
    K940176
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ackrad Laboratories
    Date Received
    January 11, 1994
    Decision Date
    April 23, 1996
    Product Code
    MFD
    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
    MFD Cannula, Intrauterine Insemination

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    Other Clearances by Ackrad Laboratories

    K Number Device Name
    K021272 SIB CATHETER, MODEL 61-7005
    K020954 H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
    K020951 H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
    K970492 INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
    K961752 H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
    K952542 ACKRAD ESOPHAGEAL BALLOON CATHETER SET
    K953034 H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
    K915813 ACKRAD ERCP CONTRAST DELIVERY SET
    K904499 NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
    K911780 INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
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