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510(k) Data Aggregation

    K Number
    K243025
    Device Name
    Ureteral Access Sheath
    Manufacturer
    SEPLOU (ZHUHAI) CO., LTD.
    Date Cleared
    2025-01-30

    (125 days)

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

    SEPLOU (ZHUHAI) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
    Device Description
    Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Ureteral Access Sheath provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. Ureteral Access Sheath comes in two models: Tip-unbendable Ureteral Access Sheath and Tip-bendable Ureteral Access Sheath with suction. The Tip-unbendable Ureteral Access Sheath is offered in French size ranging from 10Fr to 14Fr and length 28cm to 45cm. The Tip-bendable Ureteral Access Sheath with Suction is offered in French size ranging from 10Fr to 13Fr and length 33cm to 50cm.
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