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

    extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister

    K Number: K143362 · Decision Feb 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    211
    Applicant Total
    4
    Review Days
    71

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    Basic Information

    Device Name
    extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
    K Number
    K143362
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Devon Medical Products
    Date Received
    November 24, 2014
    Decision Date
    February 3, 2015
    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 Devon Medical Products

    K Number Device Name
    K161209 Cirona 6400
    K151189 Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
    K151240 extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc