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510(k) Data Aggregation

    K Number
    K231323
    Device Name
    Ancora-SB
    Manufacturer
    Aspero Medical, Inc.
    Date Cleared
    2023-08-31

    (115 days)

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

    Aspero Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0 - 9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment.
    Device Description
    The Ancora-SB is a single-use, close-fitting sleeve that slides freely over a currently marketed standard endoscope having an outer diameter of 9.0 – 9.4 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the small intestine, by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment. The device is designed to be used with a Balloon Endoscopy System (BES) which includes a multi-channel endoscope, an endoscopy tower (light source, display monitor, recording equipment, etc.) and a balloon inflation unit (equipment that inflates or deflates by a push button control, inflation is to a stated maximum pressure and the pressure is maintained during active use when inflated).
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