LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012929
    Device Name
    FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
    Manufacturer
    CIRCON VIDEO
    Date Cleared
    2001-11-19

    (80 days)

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

    FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735

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

    The intended use for the AUR-735 Flexible Pediatric Cystoureteroscope is to examine the urinary tract of pediatric patients, and with the use of additional accessories, perform various diagnostic and therapeutic procedures on pediatric patients.

    Device Description

    USA Series™ AUR™ 735 Flexible Pediatric Cystoureteroscope

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Circon Corporation regarding a medical device called the USA Series™ AUR™ 735 Flexible Pediatric Cystoureteroscope. This document confirms the FDA's finding of substantial equivalence for the device and its permitted marketing.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods. The letter is a formal communication of regulatory approval, not a scientific study report.

    Therefore, I cannot provide the requested information based solely on the input provided. The requested details would typically be found in the 510(k) submission itself, which is a much more extensive document than this approval letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1