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

    OVAMED INTRAUTERINE ACCESS CATHETER

    K Number: K931534 · Decision Jul 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    851

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    Basic Information

    Device Name
    OVAMED INTRAUTERINE ACCESS CATHETER
    K Number
    K931534
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ovamed Corp.
    Date Received
    March 29, 1993
    Decision Date
    July 28, 1995
    Product Code
    MOV
    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
    MOV Catheters, Salpingography

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