LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K080764
    Device Name
    SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
    Manufacturer
    MAX ENDOSCOPY INC.
    Date Cleared
    2008-05-06

    (49 days)

    Product Code
    ODC
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100

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

    The single-use disposable device is intended to allow the physician to temporarily increase the stiffness of a colonoscope when extra rigidity is required.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide the detailed information requested regarding the acceptance criteria, study design, and performance metrics for the "SUCCESS Cecal Intubation Assist™ Device".

    The document is a 510(k) clearance letter from the FDA, which primarily focuses on stating that the device has been found substantially equivalent to a predicate device. It specifies the regulation number, trade/device name, and indications for use. However, it does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about any specific study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

    The letter refers to a "premarket notification of intent to market the device" (510(k) submission), which would contain this information, but the submission itself is not provided here.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1