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

    IUI CATHETER, MODEL 9057

    K Number: K052059 · Decision Nov 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    52
    Applicant Total
    3
    Review Days
    116

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    Basic Information

    Device Name
    IUI CATHETER, MODEL 9057
    K Number
    K052059
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inntec, Inc.
    Date Received
    July 29, 2005
    Decision Date
    November 22, 2005
    Product Code
    MQF
    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
    MQF Catheter, Assisted Reproduction

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    Other Clearances by Inntec, Inc.

    K Number Device Name
    K051742 OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
    K050521 EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S