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510(k) Data Aggregation

    K Number
    K991855
    Manufacturer
    Date Cleared
    1999-06-15

    (14 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX

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

    CONMED Stealth® Non-Stick Accessory Electrode is designed to fit all CONMED and most other electrosurgical pencils and chuck handles and intended for use in monopolar electrosurgical procedures for the dissection and coagulation of tissue. The electrode blade is to be a direct alternative to other electrode blades in distribution and will be made available in a variety of tip configurations for differing circumstances encountered during surgical procedures.

    Device Description

    CONMED Stealth® Non-Stick Accessory Electrode is designed to fit all CONMED and most other electrosurgical pencils and chuck handles and intended for use in monopolar electrosurgical procedures for the dissection and coagulation of tissue. The electrode blade is to be a direct alternative to other electrode blades in distribution and will be made available in a variety of tip configurations for differing circumstances encountered during surgical procedures.

    AI/ML Overview

    I am sorry. This document is a letter from the FDA regarding a 510(k) clearance for a medical device (ConMed Stealth® Non-Stick Accessory Electrode). It does not contain information about acceptance criteria, study details, or performance results. This type of information is typically found in the 510(k) summary or the full submission, which is not provided here.

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