LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K963246
    Device Name
    TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
    Manufacturer
    MEDTRONIC XOMED
    Date Cleared
    1996-09-23

    (35 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 :

    TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT

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

    This device is intended for the cutting and removal of bone and tissues in ENT, otolaryngology / head and neck surgical procedures.

    Device Description

    The TreBay Microdebrider system is comprised of the Power Control unit, foot pedal and three (3) types of motorized, reusable electric handpieces that use various intercrangable cutter blades and/or bur tips. The system can operate one , two or all three handpieces (one at a time) with suction and/or irrigation, depending on the handpiece. The Microdebrider System is intended for use by health care professionals and is labeled as a restricted device.

    AI/ML Overview

    The provided 510(k) summary for the Trebay Microdebrider does not contain any information regarding acceptance criteria or a study proving the device meets them.

    This document describes a conventional surgical device (microdebrider) and focuses on its design, intended use, and substantial equivalence to existing devices. It is not a submission for an AI/ML-based medical device, which would typically require performance data against defined acceptance criteria.

    Therefore, I cannot populate the requested table and answer the subsequent questions based on the provided input. The prompt's questions are designed for AI/ML device submissions, which include specific studies to evaluate algorithm performance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1