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

    IMAGYN UROSCOPE

    K Number: K953201 · Decision Aug 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    19
    Review Days
    27

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    Basic Information

    Device Name
    IMAGYN UROSCOPE
    K Number
    K953201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical, Inc.
    Date Received
    July 6, 1995
    Decision Date
    August 2, 1995
    Product Code
    FAJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FAJ Cystoscope And Accessories, Flexible/Rigid

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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
    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. →