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510(k) Data Aggregation

    K Number
    K031029
    Device Name
    ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
    Manufacturer
    ARTHROCARE CORP.
    Date Cleared
    2003-06-19

    (79 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K003569,K955531,K010568,K020832,K022543
    Why did this record match?
    Reference Devices :

    K003569

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ArthroCare Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution, Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.

    Device Description

    The ArthroCare Bipolar Loop Electrosurgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a disposable, bipolar, single use Loop Electrode; and a reusable Patient Cable.

    AI/ML Overview

    PMA/510(k) summary does not contain the performance data. No acceptance criteria mentioned.

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