BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SINEXUS SINUS STENT GEN 2, MODEL 1999-25

    K Number: K092401 · Decision Nov 17, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    45
    Applicant Total
    1
    Review Days
    103

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    Basic Information

    Device Name
    SINEXUS SINUS STENT GEN 2, MODEL 1999-25
    K Number
    K092401
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4780
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinexus, Inc.
    Date Received
    August 6, 2009
    Decision Date
    November 17, 2009
    Product Code
    LYA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYA Splint, Intranasal Septal

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