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510(k) Data Aggregation

    K Number
    K120116
    Device Name
    SERF ABLATION SYSTEM SERF ABLATION NEEDLE
    Manufacturer
    Date Cleared
    2012-10-01

    (262 days)

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

    THERMEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SERF Ablation System is intended for the coagulation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures. The SERF Ablation System is intended for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
    Device Description
    The SERF Ablation System and SERF Ablation Needle provide heat to unwanted tissue targeted for ablation and thermal necrosis. The SERF System has these main components: 1. SERF Ablation System console which houses the RF generators, fluid pump, and system user interface. 2. System user interface, an alphanumeric display for menus and messages and a control panel which displays the set-point of each parameter of the therapy. 3. SERF Ablation Needle, a single-use, sterile device intended to penetrate tissue to locate the point of therapy initiation based on visual guidance. The SERF Needle is electrically connected to the system and delivers RF energy and warm saline to the tissue through perforations in the shaft near the needle tip. 4. A sterile single-use syringe for use with the SERF system is commercially available. 5. Return electrode pads and cables for use with the SERF System are commercially available, The SERF system is a monopolar electrosurgical device.
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