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

    Nisus NPWT Canister 500-mL (CPC-500)

    K Number: K261291 · Decision May 21, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    4
    Review Days
    31

    Basic Information

    Device Name
    Nisus NPWT Canister 500-mL (CPC-500)
    K Number
    K261291
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cork Medical
    Date Received
    April 20, 2026
    Decision Date
    May 21, 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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    Other Clearances by Cork Medical

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    K241061 VERSA Negative Pressure Wound Therapy System (VCMPP-100)
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