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510(k) Data Aggregation

    K Number
    K223377
    Device Name
    BIASURGE Advanced Surgical Solution
    Date Cleared
    2023-03-30

    (146 days)

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

    Rochal Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Biasurge Advanced Surgical Solution is indicated for use in mechanical cleansing and removal of debris, including microorganisms from wounds.
    Device Description
    BIASURGE Advanced Surgical Solution is a clear, colorless solution intended for cleansing and removal of debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganism, from wounds. BIASURGE Solution is provided in a soft polypropylene 1000mL container with a spikeable port. BIASURGE Solution is composed of Purified Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Hypromellose, Octane-1,2-diol, Polyaminopropyl Biguanide [PHMB; a preservative], EDTA Disodium, EDTA Trisodium.
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