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510(k) Data Aggregation

    K Number
    K020310
    Device Name
    DAVLITE MICROENDOSCOPE & ACCESSORIES
    Manufacturer
    DAVLITE TECHNOLOGIES
    Date Cleared
    2002-03-20

    (50 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K011189,K932987
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAVLITE TECHNOLOGIES

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

    This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.

    Device Description

    The Davlite Microendoscope is a semi-rigid fiberscope with a single use sheath and a re-useable (reposable) microendoscope. The microendoscope is provided and labeled nonsterile. The microendoscope must be sterilized prior to use. (See instructions for cleaning and sterilization).

    AI/ML Overview

    This document does not contain information about acceptance criteria, device performance, sample size, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, or training set details. The provided text is a summary of safety and effectiveness, an FDA 510(k) clearance letter, and an indications for use statement for the Davlite Microendoscope. It focuses on the regulatory aspects of the device, its intended use, and substantial equivalence to predicate devices, rather than detailed performance evaluations or clinical study results.

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