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510(k) Data Aggregation

    K Number
    K973504
    Device Name
    UROSURGE UROSTENT
    Manufacturer
    PRINCETON REGULATORY ASSOC.
    Date Cleared
    1998-01-30

    (136 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UROSURGE UROSTENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UroSurge UroStent™ is intended to be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or open surgical techniques. The duration of the placement of these stents must not remain indwelling more than twenty nine (29) days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents do not contain information about acceptance criteria or a study that proves the UroSurge UroStent™ meets acceptance criteria. The documents are a 510(k) clearance letter from the FDA and an Indications For Use Statement. They confirm the device's substantial equivalence to previously marketed devices and define its intended use, but they do not describe performance metrics, study designs, or data analysis related to specific acceptance criteria.

    Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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