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510(k) Data Aggregation

    K Number
    K172593
    Device Name
    XCelliStem Wound Powder
    Manufacturer
    Date Cleared
    2018-03-16

    (199 days)

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

    StemSys

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XCelliStem Wound Powder is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
    Device Description
    The XCelliStem Wound Powder is an extracellular matrix composed of porcine collagen for the management of wounds. It is white to off-white particulate that is to be used as a topical application. The product is provided sterile, for single use.
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