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510(k) Data Aggregation

    K Number
    K990586
    Device Name
    CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES
    Manufacturer
    CONMED CORP.
    Date Cleared
    1999-05-17

    (83 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES

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

    Sterile, single-use electrosurgical accessory used in conjunction with an ABC® generator for delivery of agron gas and electrosurgical current through a flexible endoscope to perform coagulation.

    Device Description

    ConMed ABC® Probe for Flexible Endoscopes

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for the ConMed ABC® Probe for Flexible Endoscopes. It does not contain information about acceptance criteria or specific study details that would allow me to populate the requested table and answer the questions. The letter primarily confirms that the device is substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

    Therefore, I cannot provide the requested information based on the provided text.

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