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510(k) Data Aggregation

    K Number
    K242668
    Device Name
    Gastro Concepts Air Assist
    Manufacturer
    Gastro Concepts, LLC
    Date Cleared
    2024-12-13

    (99 days)

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

    Gastro Concepts, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Air Assist is intended to slide over the outer surface of an endoscope to facilitate endoscopic therapy by providing a manual, reversible method to control the insufflation (air/CO2) so the physician can better maintain an appropriate field of view.
    Device Description
    The Gastro Concepts Air Assist Device is a single-use device that is used to aid in maintaining air/CO2 and insufflation during a colonoscopy. The Air Assist, a single-use device, comprises a cylindrical body with a conical-shaped tip and an open channel for endoscope insertion. Positioned against the anus (not inserted into the rectum), it forms a temporary seal, maintaining air/CO2 insufflation leading to adequate colonic distension for enhanced visualization.
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