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510(k) Data Aggregation

    K Number
    K232464
    Device Name
    VereSee Optical Veres Needle System
    Manufacturer
    Freyja Healthcare, LLC
    Date Cleared
    2024-05-02

    (261 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Freyja Healthcare, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VereSee Optical Veres Needle System is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic surgery.
    Device Description
    The VereSee Optical Veres Needle System is comprised two components: 1) Optical Veres Needle, and 2) Camera Control Unit. The Optical Veres Needle consists of a series of three concentric, stainless steel cannulas with a handle and an umbilical cable to connect it to the VereSee Camera Control Unit. The device is provided sterile for single-patient use. The Outer Cannula provides a luer fitting for connection of insufflation tubing with an integral flow control stopcock and a set of seals to prevent leakage of insufflation gas. The Central Cannula consists of a stainless steel hypo tube with a clear, point tip for penetration and visualization during abdomen penetration. The Inner Cannula is composed of a stainless steel hypo tube with a CMOS camera surrounded by light fibers at its tip. The light fibers carry the light from an integral LED which is mounted to a heat sink to distribute heat from the LED. The VereSee Camera Control Unit connects the CMOS camera in the Optical Veres Needle to HDMI compatible monitors to provide an image for laparoscopic procedures. The VereSee Camera Control Unit (CCU) includes an LED driver to power the LED. The CCU connects to the Optical Veres Needle via an umbilical cable. The VereSee Camera Control Unit converts signals from the CMOS camera in the Optical Veres Needle to a format compatible with HDMI display input requirements.
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