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510(k) Data Aggregation

    K Number
    K972057
    Device Name
    POWERTREK INSTRUMENTS
    Manufacturer
    MEDTREK CORP.
    Date Cleared
    1997-11-05

    (156 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PowerTREK Instrument is indicated for use in the removal of tissue or bone in minimally invasive ENT and ,Orthopedic procedures. It is to be used within a surgical setting under sterile technique.

    Device Description

    Not Found

    AI/ML Overview

    There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for the PowerTREK Micro Debrider System, indicating that the device has been found substantially equivalent to predicate devices. It discusses regulatory classifications and general controls but does not contain details about specific performance studies, sample sizes, expert involvement, or adjudication methods.

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