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510(k) Data Aggregation

    K Number
    K981041
    Device Name
    SLT BIPOLAR SHEATH
    Manufacturer
    SURGICAL LASER TECHNOLOGIES, INC.
    Date Cleared
    1998-08-27

    (160 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SLT BIPOLAR SHEATH

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

    The SLT Bipolar Sheath is indicated for use with currently marketed debrider system tips used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip.

    Device Description

    The SLT bipolar sheath is indicated for use with currently marketed debrider systems used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.

    AI/ML Overview

    This document is a 510(k) summary for the SLT bipolar sheath and does not contain the information requested in your prompt. The provided text is a regulatory submission for a medical device that details its intended use, technological features, and substantial equivalence to legally marketed predicate devices. Key information such as acceptance criteria, study data, sample sizes, expert qualifications, and ground truth establishment are not included.

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