LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K131323
    Device Name
    ECLERIS SINUSCOPE
    Manufacturer
    Ecleris USA
    Date Cleared
    2014-06-09

    (397 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended to be a reusable instrument to provide the physician with a means for direct viewing of the nasal cavity by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.

    Device Description

    Ecleris Sinuscope

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA for the Ecleris Sinuscope. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document does not contain the information requested in points 1-9.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1