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510(k) Data Aggregation

    K Number
    K030172
    Device Name
    SMALL HIGH SPEED MOTOR DRILL SYSTEM
    Manufacturer
    BRASSELER USA I, L.P.
    Date Cleared
    2003-04-03

    (76 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SMALL HIGH SPEED MOTOR DRILL SYSTEM

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

    THE SMALL HIGH SPEED DRICE SYSTEM IS INTENDED FOR RAPID DISSEETTON OF BONE, BOPLASTICS AND BIOMATERIALS DURING NEUROSURGICAL, ENT AND MAXILLOFACIAL SURGICAL PROCEDURES

    Device Description

    SMALL MIGH SPEED MOTOR DRILL SYSTEMS

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a "Small High Speed Motor Drill System." It confirms that the device is substantially equivalent to a legally marketed predicate device.

    However, this document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    The letter is a regulatory approval document and does not detail the technical performance studies that would have been submitted as part of the 510(k) application. To answer your questions, one would need to access the actual 510(k) submission documentation, which is not provided here.

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