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510(k) Data Aggregation

    K Number
    K253531

    Validate with FDA (Live)

    Date Cleared
    2026-02-23

    (102 days)

    Product Code
    Regulation Number
    878.4370
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Alexis Lighted Wound Protector-Retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to provide supplemental illumination and protect against wound contamination during both laparoscopic and open surgery. The Alexis Lighted Wound Protector-Retractor is capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery, or to serve as an additional trocar port site. In addition, the device may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures.

    Device Description

    Applied Medical's Alexis Lighted Wound Protector-Retractor provides wound protection and retraction during laparoscopic and open surgery while providing supplemental illumination. The device is provided sterile, and the reusable power supply is provided non-sterile. The device and power supply are used in the clinical setting.

    The system includes five main components:

    • A sheath that protects the wound and provides retraction with tension applied.
    • An outer ring that is rolled to create tension on the sheath and anchor the device.
    • An inner ring with embedded LEDs that anchors the device and provides illumination.
    • A power cord that connects to the reusable power supply.
    • A reusable power supply that connects to a grounded receptable to provide power to the LEDs.
    AI/ML Overview

    N/A

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