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510(k) Data Aggregation

    K Number
    DEN210049
    Device Name
    Medline ART Skin Harvesting System
    Manufacturer
    Medline Industries, Inc
    Date Cleared
    2024-03-27

    (890 days)

    Product Code
    QYK, OYK
    Regulation Number
    878.4795
    Why did this record match?
    Product Code :

    QYK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ART (Autologous Regeneration of Tissue) Skin Harvesting System is intended for the harvesting and application of autologous, full thickness micrografts for wounds where autologous skin grafting would be appropriate.
    Device Description
    The device is a handheld surgical skin tissue harvesting system that uses an array of coring needles to acquire full thickness skin tissue columns (hereafter referred to as "micrografts" or "microcolumns") from an appropriate healthy donor site for deposition onto an appropriate recipient treatment site (Figure 1). The procedure is minimally invasive and both the tissue acquisition (i.e., "harvest") and deposition (i.e., "scatter") processes are automatically performed by a handheld device as described below. The device consists of three components: (1) a non-sterile, reusable handheld device; (2) a sterile, single-patient use needle cartridge containing the needle array for harvesting skin micrografts from the patient donor site; and (3) a sterile, single-patient use handheld protective sleeve to cover the handheld device (Figure 2). The handheld device uses embedded software to control the operation of the cartridge using user-activated tactile buttons and trigger (Figure 3). The sterile sleeve protects the handheld device from soilage and provides a physical barrier between the non-sterile handheld device and the patient.
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