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

    IMAGYN FALLOPOSCOPY SYSTEM

    K Number: K963580 · Decision Jan 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    19
    Review Days
    147

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    Basic Information

    Device Name
    IMAGYN FALLOPOSCOPY SYSTEM
    K Number
    K963580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical, Inc.
    Date Received
    September 6, 1996
    Decision Date
    January 31, 1997
    Product Code
    MKO
    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
    MKO Falloposcope

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    Other Clearances by Imagyn Medical, Inc.

    K Number Device Name
    K972426 MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH
    K970750 MICROSPAN INSEMINATION SYSTEM
    K971255 IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
    K965055 IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
    K961688 MICROSPAN HYSTEROSCOPE
    K961506 MICROSPAN HYSTEROSCOPE SHEATH
    K952032 IMAGYN HYSTEROSCOPE SHEATHS
    K951996 IMAGYN ENDOSCOPE
    K951974 IMAGYN ENDOSCOPE SHEATH
    K953201 IMAGYN UROSCOPE
    Search all 19 clearances from Imagyn Medical, Inc. →