LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K092401
    Device Name
    SINEXUS SINUS STENT GEN 2, MODEL 1999-25
    Manufacturer
    SINEXUS, INC.
    Date Cleared
    2009-11-17

    (103 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    SINEXUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sinexus Sinus Stent Gen 2 is intended for use in adult patients following sinus surgery to maintain patency of the sinus by separating mucosal tissues, providing stabilization of the middle turbinate and preventing obstruction by adhesions between healing and/or inflamed mucosal surfaces.
    Device Description
    The Gen 2 Sinexus Sinus Stent is a bioabsorbable stent designed to be placed in the ethmoid sinus to maintain patency of the sinus after surgery.
    Ask a Question

    Page 1 of 1