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510(k) Data Aggregation

    K Number
    K251469

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (220 days)

    Product Code
    Regulation Number
    876.4620
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is indicated to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions in the ureter. The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic techniques. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.

    Device Description

    The subject devices are coated ureteral stent that are supplied as a standalone product (including a pigtail straightener) or as part of a set, available in two configurations:

    • Basic Set: Includes a ureteral stent, pigtail straightener, and positioner.
    • Full Set: Includes a ureteral stent, pigtail straightener, positioner, and J-tip guide wire.

    The coated stents are flexible tubular devices made of radiopaque polyurethane, featuring self-retaining coiled pigtail structures at both ends. The stent body incorporates multiple drainage holes to ensure smooth urine flow from the renal pelvis to the bladder. The dual-pigtail design positions the proximal end in the renal pelvis and the distal end in the bladder. Additionally, the stent surface is marked with graduated scales for precise intraoperative positioning.

    AI/ML Overview

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