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510(k) Data Aggregation

    K Number
    K101372
    Device Name
    DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Date Cleared
    2010-08-10

    (85 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K092337
    Why did this record match?
    Reference Devices :

    K092337

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

    The DuoCool Pain Management Probe (probe model number: OSP-17-180-20; kit model number: OSK-17-180-20) is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain

    Device Description

    The DuoCool Pain Management Probe is a sterile, single-use probe used to deliver Radio-Frequency (RF) energy while being cooled.

    AI/ML Overview

    This document is a 510(k) summary for the DuoCool Pain Management Probe. It establishes substantial equivalence to a predicate device and does not contain acceptance criteria or study results that demonstrate the device meets specific performance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence rather than detailed performance study data against acceptance criteria.

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