LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020354
    Device Name
    BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Date Cleared
    2002-05-03

    (88 days)

    Product Code
    GXD,GEI
    Regulation Number
    882.4400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)

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

    Baylis Pain Management Generator; Model PMG-115 (For Domestic Use) and Model PMG-230 (For International Use) is indicated for use to create lesions during neurological lesion procedures. The Baylis PMG is to be used with separately approved lesion/temperature probes such as Baylis Pain Management Probes and Oratec Spinecath™.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device, the Baylis Pain Management Generator. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information from the provided text. The document is an FDA clearance and approval letter, not a device performance study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1