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510(k) Data Aggregation

    K Number
    K232805
    Device Name
    Kronos Electrocautery Device
    Manufacturer
    Date Cleared
    2024-04-25

    (226 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Single Pass, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kronos Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver, kidney, and lung soft tissue.
    Device Description
    The Kronos Electrocautery Device is a single-use, disposable and battery-operated electrocautery device utilized to control bleeding post-biopsy procedure of solid organs (i.e., liver, kidney, lungs, etc.). The Kronos electrosurgical device consists of: - a power supply: Two AA batteries - a Stainless Steel (SS) distal probe with a rounded heated tip that is connected to the handle to cauterize targeted areas of tissue. The tip is heated (75 °C - 100 °C) via electrical current through a coiled wire. The temperature of the distal tip is controlled with a thermistor while the temperature of the tip is distributed with a thermal conductive epoxy. - The ergonomic handle includes an on/off switch and a push button to activate the heated tip. Kronos Electrocautery Device is available in two models, K10 and K15. K10 model is compatible with 10cm guide needle whereas K15 is compatible with 15cm guide needle.
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