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510(k) Data Aggregation

    K Number
    K974637
    Device Name
    ELECTRODES/PROBES/DEVICES
    Manufacturer
    XIMED/PROSURE/INJECTX
    Date Cleared
    1998-01-07

    (26 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K020069,K072318,K964818
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The electrosurgical probes and devices are to be used with commercially available R.F. generators, endoscopes including hysteroscopes, resectoscopes, cystoscopes and laparoscopes, suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.

    Device Description

    Electrodes/Probes/Devices

    AI/ML Overview

    This is a 510(k) premarket notification letter from the FDA to Ximed Medical/ProSurg, Inc. regarding their "Electrodes/Probes/Devices."

    The document states that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to predicate devices. This letter approves the device for marketing.

    However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    The information provided (K974637) is a regulatory approval document, not a clinical study report or a performance specification document. Therefore, I cannot extract the requested information from the provided text.

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