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510(k) Data Aggregation

    K Number
    K150852
    Device Name
    SIC 8000
    Manufacturer
    COSMO TECHNOLOGIES, LTD.
    Date Cleared
    2015-09-03

    (156 days)

    Product Code
    PLL
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMO TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.
    Device Description
    SIC 8000 is an injectable liquid composition in the form of an oil-in-water (o/w) emulsion for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, such as the esophagus, the small intestine, the colon, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy. SIC 8000 is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The emulsion, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).
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