BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    RENASYS EDGE (66803126)

    K Number: K260646 · Decision May 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    8
    Review Days
    89

    Basic Information

    Device Name
    RENASYS EDGE (66803126)
    K Number
    K260646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Medical, Ltd.
    Date Received
    February 27, 2026
    Decision Date
    May 27, 2026
    Product Code
    OMP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OMP Negative Pressure Wound Therapy Powered Suction Pump

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