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

    Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)

    K Number: K234107 · Decision Apr 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    30
    Applicant Total
    5
    Review Days
    119

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    Basic Information

    Device Name
    Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
    K Number
    K234107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laborie Medical Technologies, Corp.
    Date Received
    December 26, 2023
    Decision Date
    April 23, 2024
    Product Code
    KLA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube

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