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510(k) Data Aggregation

    K Number
    K243152
    Device Name
    GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
    Manufacturer
    Applied Medical Resources Corp.
    Date Cleared
    2025-10-02

    (367 days)

    Product Code
    HEW
    Regulation Number
    884.1640
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K191294
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and maintain insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device may be used for sentinel pelvic lymph node dissection occurring in the retroperitoneal space. The device is also a conduit for the extraction of specimens

    Device Description

    The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device consists of an intraperitoneal Alexis retractor and retroperitoneal Alexis retractor that are placed transvaginally to create a pathway to the peritoneum and retroperitoneum. A GelSeal cap attaches to the retractors at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm laparoscopic instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

    AI/ML Overview

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