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510(k) Data Aggregation

    K Number
    K182159
    Device Name
    Strome-Blitzer Cytology Balloon
    Manufacturer
    ADN International LLC
    Date Cleared
    2019-06-13

    (308 days)

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

    ADN International LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Strome-Blitzer Cytology Balloon device is indicated for use in the 4-quadrant collection and retrieval of surface cells from the esophagus in adults (22 years of age or older). The device may be delivered transorally under direct endoscopic visualization.
    Device Description
    The Strome-Blitzer Cytology Balloon is an inflatable biopsy platform. It consists of a catheter with a silicone balloon at its distal end. The balloon has 6 collection pleats on its surface. Inside each pleat are 2 cytology collection strips for specimen collection. While the balloon is uninflated, the strips are covered by the balloon pleats. When inflated, the strips are exposed. The balloon inflates and deflates with the use of a syringe and attached catheter, and is a sterile, single-use device. There are 4 location indicator dots on the proximal balloon surface for orientation during esophagoscopy.
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