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510(k) Data Aggregation

    K Number
    K972865
    Device Name
    PROMEX ENT TISSUE REMOVAL SYSTEM
    Manufacturer
    PROMEX, INC.
    Date Cleared
    1997-09-29

    (56 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROMEX ENT TISSUE REMOVAL SYSTEM

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

    For the removal of soft tissue and bone in the ear, nose & throat.

    Device Description

    Promex ENT Tissue Removal System

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for the Promex ENT Tissue Removal System, dated September 29, 1997. This document approves the device for marketing and confirms its substantial equivalence to previously marketed devices.

    This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt.

    The letter explicitly states that the device is approved "for the indications for use stated in the enclosure," which on the second page is "For the removal of soft tissue and bone in the ear, nose & throat."

    Since the document is a regulatory approval letter and not a study report, it does not provide the requested information regarding the performance study that would typically establish acceptance criteria and demonstrate device effectiveness.

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