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510(k) Data Aggregation

    K Number
    K021299
    Device Name
    CONMED HEATWAVE HAND-CONTROLLED ELETRODE
    Manufacturer
    CONMED CORP.
    Date Cleared
    2002-06-26

    (63 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K050923
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures. Additionally, the SI version also has suction capability.

    Device Description

    Not Found

    AI/ML Overview

    This is a regulatory letter from the FDA regarding the Conmed Heatwave Hand-Controlled Electrode. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it mention AI-related performance or studies.

    Therefore, I cannot provide the requested information. The document focuses on the substantial equivalence determination for a traditional electrosurgical device based on pre-amendment devices, not on performance studies with acceptance criteria, human readers, or AI.

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