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    K Number
    K031951
    Device Name
    TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Date Cleared
    2003-09-11

    (79 days)

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

    TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6

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

    The Transdiscal system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs

    Device Description

    Transdiscal System

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a medical device (Transdiscal System), indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the product name, regulation number, regulatory class, and intended use, but it does not include detailed study results or performance metrics as requested in your prompt.

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