LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023257
    Device Name
    ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
    Manufacturer
    PROSURG, INC.
    Date Cleared
    2003-03-28

    (179 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indications For Use:

    Endoscopic Laser Delivery System -LaserTx

    The Endoscopic Laser Delivery System -LaserTx with diffuser -tip fiberoptic delivery catheter is indicated for general tissue coagulation & ablation during general surgery, general grological, general gynecological and general gastroenterological procedures , and Endoscopic laser coagulation of turnors , fibroids and other soft tissue.

    The Endoscopic Laser Delivery System -Laser Tx with bare -tip fiberoptic is indicated for the incision, excision, and ablation or coagulation of tissues with hemostatis during general surgery, and general gastroenterological and urological procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Endoscopic Laser Delivery System - LaserTx." This document confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements.

    However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The letter focuses on regulatory approval based on equivalence and not on specific performance metrics or clinical study results.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1