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510(k) Data Aggregation

    K Number
    K240776
    Device Name
    Celsio Flexible Cryocatheter System
    Manufacturer
    Endocision Technologies Inc.
    Date Cleared
    2024-09-24

    (187 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    Endocision Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Celsio Flexible Cryocatheter System is intended for cryoadhesion applications during interventional procedures such as the removal of tissue, foreign bodies, mucous plugs, blood clots, necrotic tissue, tumors and tissue biopsies, and for palliative devitalization (destruction) of tissue by the application of extreme cold.
    Device Description
    The Celsio Flexible Cryocatheter System is a cryosurgical device with a disposable carbon dioxide (CO2) cartridge that is used with commercially available endoscopes with a minimum working channel diameter of 2mm and maximum working length of 1052 mm, in interventional endoscopic procedures. The Celsio Flexible Cryocatheter System is comprised of a Flexible Cryocatheter (sterile, single use), a CO2 Refrigerant Cartridge (non-sterile, single use) and a Refrigerant Dispenser (nonsterile, single use). The flexible cryocatheter is typically delivered using a compatible endoscope to the target location. Once the refrigerant dispenser is activated, pressurized refrigerant fluid is delivered to the catheter tip where it undergoes expansion to its lower temperature (the Joule-Thomson effect), causing surrounding tissue in contact with the catheter tip to freeze and adhere.
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