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510(k) Data Aggregation

    K Number
    K233142
    Device Name
    EndoSign® Cell collection device (ES-CYT-102)
    Manufacturer
    Cyted Limited
    Date Cleared
    2024-01-19

    (114 days)

    Product Code
    EOX
    Regulation Number
    874.4710
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cyted Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoSign® Cell collection device is to be used for the collection of cells from the surface of the oesophagus for molecular, cytological and histological analyses.
    Device Description
    The EndoSign® Cell collection device is to be used for the collection of cells from the surface of the oesophagus for molecular, cytological and histological analyses. It is a non-sterile low risk, transient use, minimally invasive, single use, oesophageal cell collection device designed for use by trained and qualified medical professionals. The device is composed of a clear, size 00 capsule made from vegetable-derived material. The capsule houses a 30mm compressed spherical sponge and is connected to a non-absorbable silicone-coated braided polyester thread, secured to a clear polycarbonate applicator. The patient swallows the capsule along with the bundled thread, and as it travels through the oesophagus, the capsule dissolves allowing the sponge to expand and release. The thread is then gently pulled to retrieve the sponge, which collects cells from the lining of the oesophagus as it is removed. The device is used to collect cell samples which are further analyzed for identification of disease biomarkers. The results of the test will be used to assess patients suspected of oesophageal pathologies such as Barrett's oesophageal cancer, eosinophilic esophagitis, and other abnormalities.
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