BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)

    K Number: K251499 · Decision Jun 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    236
    Applicant Total
    1
    Review Days
    27

    Basic Information

    Device Name
    Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
    K Number
    K251499
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    William Cook Europe Aps
    Date Received
    May 15, 2025
    Decision Date
    June 11, 2025
    Product Code
    BTR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTR Tube, Tracheal (W/Wo Connector)

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