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

    NEO-VAGINA SURGERY SET AND ACCESSORIES

    K Number: K071754 · Decision Jan 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    8
    Applicant Total
    334
    Review Days
    559

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    Basic Information

    Device Name
    NEO-VAGINA SURGERY SET AND ACCESSORIES
    K Number
    K071754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.3900
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    June 28, 2007
    Decision Date
    January 7, 2009
    Product Code
    HDX
    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
    HDX Dilator, Vaginal

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