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510(k) Data Aggregation

    K Number
    K190386
    Device Name
    KTA Adipose Treatment Kit
    Manufacturer
    Stemics S.A.S
    Date Cleared
    2019-10-10

    (233 days)

    Product Code
    MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stemics S.A.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KTA Adipose Treatment Kit is intended for medical and surgical procedures involving autologous fat grafting that consists in: -harvesting, -centrifuging, and -reinjecting autologous adipose tissue, Within the same procedure. The KTA Adipose Treatment Kit range consists in a family of products which are designed to harvest, process with minimal manipulation and reinject small - KTAMICRO, KTAEASY, KTAMY - to large -KTAMACRO, KTAMACROMED, KTASPIN - volumes of autologous fat in the following specialties: Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Arthroscopic Surgery,
    Device Description
    The KTA Adipose Treatment Kit consists of a sterile (EtO) single use disposable pack used for the aspiration, harvesting, centrifuging and reinjection of autologous adipose tissue during the same procedure. Each kit contains the necessary equipment such as syringes, cannulas, needles, containers, Luer Lock caps / connectors and a standard M8 single use nut for the centrifuge
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