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510(k) Data Aggregation

    K Number
    K240975
    Device Name
    Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)
    Date Cleared
    2024-12-23

    (257 days)

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

    Beijing Taktvoll Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
    Device Description
    The ES-100 and ES-300 Electrosurgical Generator are advanced high-frequency surgical devices designed to provide versatility and safety in various surgical procedures. Both models offer a range of operating modes, including monopolar electrosurgical excision modes, monopolar electrocoagulation modes, and bipolar modes, catering to the diverse needs of surgeons. The maximum output power of the ES-100 is 100 W, while the ES-300 offers increased output power of up to 300 W, providing surgeons with enhanced capabilities for cutting and coagulation in various surgical procedures. Both models are equipped with manual and foot switch controls, allowing for seamless operation during surgeries. They feature volume control for adjusting the device's audio output, memory functions for storing recent settings, and built-in return electrode monitor systems for real-time safety monitoring.
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