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510(k) Data Aggregation

    K Number
    K230593
    Device Name
    Victan
    Date Cleared
    2023-05-30

    (88 days)

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

    Jiangsu Haize Medical Scientific Development Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Victan is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
    Device Description
    The Single Use Surgical Electrocoagulator is a sterile, single-patient-use electrosurgical accessory, and deliver electrical current from high-frequency generator to the surgical site. At the same time, the product can also provides suction or irrigation by connecting to a negative pressure drainage device. The proposed product consists of Electrode, External tube, Irrigation and suction tube, External tube control button, Rotator, Irrigation switch, Suction switch, Handle, Suction connecting tube, Suction connector, Irrigation connector, Cable, Irrigation connecting tube, Outer tube.
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