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

    VisionAir Enhanced Stock Stent

    K Number: K261541 · Decision Jun 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    24

    Basic Information

    Device Name
    VisionAir Enhanced Stock Stent
    K Number
    K261541
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3720
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VisionAir Solutions
    Date Received
    May 8, 2026
    Decision Date
    June 1, 2026
    Product Code
    NWA
    Advisory Committee
    General, Plastic Surgery
    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
    NWA Prosthesis, Tracheal, Preformed/Molded

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