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510(k) Data Aggregation

    K Number
    K222575
    Device Name
    HurriChem Device Kit
    Date Cleared
    2022-12-06

    (103 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ThermaSolutions LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ThermaSolutions HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.
    Device Description
    ThermaSolutions' HurriChem Device Kit consists of the HurriChem Irrigation Wand and braided poly tubing. The HurriChem Device Kit is intended for use to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures. It is designed to lavage blood and tissue debris from the surgical site. The kit is to be used in conjunction with standard injection pumps. The kit is to be used only by physicians trained in the use of this device. The device is packaged and sterilized for single use only, and should be discarded after use according to the policy of the facility. The HurriChem Device Kit consists of a stainless-steel wand and a length of braided poly tubing. The one end of the tubing attaches to the stainless-steel wand, and the other end of the tubing is intended to attach to a standard injection pump (not part of the device). The sterile fluid is delivered from the injection pump through the poly tubing and into the stainless-steel wand. The wand has internal mechanics that deliver the fluid as microscopic droplets in a fine mist. The irrigation using fluid droplets allows for maximum lavage of the area with a minimal amount of fluid.
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