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

    SONOHYSTEROGRAPHY BIOPSY DEVICE

    K Number: K060908 · Decision Jun 29, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    104
    Review Days
    87

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    Basic Information

    Device Name
    SONOHYSTEROGRAPHY BIOPSY DEVICE
    K Number
    K060908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Urological, Inc.
    Date Received
    April 3, 2006
    Decision Date
    June 29, 2006
    Product Code
    PGK
    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
    PGK Cannula, Injector, Uterine, Endometrial Biopsy

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