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510(k) Data Aggregation

    K Number
    K151168
    Device Name
    Nexodyn AOS Wound Care Solution
    Date Cleared
    2015-12-22

    (235 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    APR Applied Pharma Research SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nexodyn AOS Wound Care Solution is intended for use under the supervision of healthcare professionals for cleansing, irrigating, moistening and debriding, to remove organic debris from partial or full thickness acute and chronic dermal lesions, such as leg ulcers, diabetic ulcers, stage I-IV pressure ulcers, post-surgical wounds, grafted and donor sites and 1st and 2nd degree burns, together with cleansing and moistening minor burns, superficial abrasions and minor skin irritations.
    Device Description
    Nexodyn AOS Wound Care Solution is a clear, liquid solution wound cleanser that helps maintain a moist wound environment by removing dirt, debris and foreign material by the action of the wound cleanser moving across the wound bed. The device contains hypochlorous acid (HClO) acting as a preservative by inhibiting the growth of microorganisms within the solution. The principle of operation of Nexodyn AOS Wound Care Solution to be irrigated across the wound being treated, by using bottles with a spray cap or by sluicing with larger quantity of solution from an open bottle. The mechanism of action of Nexodyn AOS Wound Care Solution is based on the mechanical action of the solution flowing through the lesion and removing biological and inert materials such as microorganisms, biological debris and environmental dirt. Nexodyn AOS Wound Care Solution is obtained by electrolysis, carried out on a saline solution, the starting raw materials being water and sodium chloride.
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