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

    MICROSPAN INSEMINATION SYSTEM

    K Number: K970750 · Decision May 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    28
    Applicant Total
    19
    Review Days
    63

    Basic Information

    Device Name
    MICROSPAN INSEMINATION SYSTEM
    K Number
    K970750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    IMAGYN MEDICAL, INC.
    Date Received
    March 3, 1997
    Decision Date
    May 5, 1997
    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 IMAGYN MEDICAL, INC.

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    K965055 IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
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    K961506 MICROSPAN HYSTEROSCOPE SHEATH
    K952032 IMAGYN HYSTEROSCOPE SHEATHS
    K951996 IMAGYN ENDOSCOPE
    K951974 IMAGYN ENDOSCOPE SHEATH
    K953201 IMAGYN UROSCOPE
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