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510(k) Data Aggregation

    K Number
    K251899
    Device Name
    E Blator
    Date Cleared
    2025-10-01

    (103 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The E Blator is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution.

    Device Description

    The device is equipped with a patented stainless steel electrode tip encased in a thermal insulator. When used in combination with a compatible electrosurgical generator, the device provides radio frequency (RF) energy for cutting, vaporizing, and coagulating soft tissue. The device enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect with handswitch control, said current then returns back to the electrosurgical unit through the return electrode and connector. This provides the capability for the surgeon to balance tissue dissection and hemostatic effects as needed during a given surgical case. For aspirating models, when coupled with a vacuum system, the surgical field can be cleared of undesirable debris simultaneously by using the aspiration port located at the bottom of the face of the electrode. Removing this debris can facilitate the surgeon's visualization of the surgical field.

    AI/ML Overview

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