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510(k) Data Aggregation

    K Number
    K071745
    Device Name
    BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Date Cleared
    2007-07-19

    (22 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K002389
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Baylis Pain Management Single-Use Probe will be used in conjunction with a Baylis Pain Management Connector Cable and the Baylis Pain Management Generator to create radiofrequency lesions in nervous tissue.

    Device Description

    The Baylis Pain Management Single-Use Probe is a sterile, single-use device that delivers Radiofrequency (RF) energy.

    AI/ML Overview

    The provided text is a 510(k) summary for the Baylis Pain Management Single-Use Probe. It describes the device, its intended use, and its substantial equivalence to a predicate device.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot provide the requested table and study details based on the input text. The 510(k) summary focuses on demonstrating equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

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