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510(k) Data Aggregation

    K Number
    K242336
    Device Name
    hygh-tec Drainage II
    Manufacturer
    AMB Medtec
    Date Cleared
    2025-01-17

    (163 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMB Medtec

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hygh-tec drainage II is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.
    Device Description
    The hygh-tec drainage II is a fecal drainage system that is comprised of a stool collection bag, and an inflating syringe. The device is used by healthcare professional heatthcare environment for continuous trans-anal drainage and collection of stools. The stool drainage tool is the patient while a liquid is infused within a specialized port to irigate the rectum. The organic matter then progresses through the drainage tube where it is eventually stored in the collection bag for evaluation or disposal. Along with stool drainage, the hygh-tec drainage II system can be used for the administration that would be prescribed by physicians.
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