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

    THECURVE, ITEM 507

    K Number: K012935 · Decision Oct 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    28
    Applicant Total
    6
    Review Days
    41

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    Basic Information

    Device Name
    THECURVE, ITEM 507
    K Number
    K012935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Select Medical Systems, Inc.
    Date Received
    August 31, 2001
    Decision Date
    October 11, 2001
    Product Code
    MFD
    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
    MFD Cannula, Intrauterine Insemination

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    Other Clearances by Select Medical Systems, Inc.

    K Number Device Name
    K974819 SELECTCELLS(TM) MINI
    K954099 SELECT IUI
    K954097 SELECTCELLS STANDARD
    K954102 SELECTMUCUS
    K942922 SELECTA 20/60 CHEMISTRY ANALYZER