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

    extriCARE® 1000 Negative Pressure Wound Therapy System

    K Number: K251646 · Decision Oct 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    2
    Review Days
    127

    Basic Information

    Device Name
    extriCARE® 1000 Negative Pressure Wound Therapy System
    K Number
    K251646
    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
    Alleva Medical Devices
    Date Received
    May 29, 2025
    Decision Date
    October 3, 2025
    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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    Other Clearances by Alleva Medical Devices

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    K221223 extriCARE® 3000 Negative Wound Pressure Therapy System