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

    IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING

    K Number: K940425 · Decision Aug 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    56
    Applicant Total
    19
    Review Days
    182

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    Basic Information

    Device Name
    IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
    K Number
    K940425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical, Inc.
    Date Received
    January 31, 1994
    Decision Date
    August 1, 1994
    Product Code
    MAV
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAV Syringe, Balloon Inflation

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    Other Clearances by Imagyn Medical, Inc.

    K Number Device Name
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    K970750 MICROSPAN INSEMINATION SYSTEM
    K971255 IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
    K965055 IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
    K963580 IMAGYN FALLOPOSCOPY SYSTEM
    K961688 MICROSPAN HYSTEROSCOPE
    K961506 MICROSPAN HYSTEROSCOPE SHEATH
    K952032 IMAGYN HYSTEROSCOPE SHEATHS
    K951996 IMAGYN ENDOSCOPE
    K951974 IMAGYN ENDOSCOPE SHEATH
    Search all 19 clearances from Imagyn Medical, Inc. →