LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012951
    Device Name
    APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
    Manufacturer
    CIRCON VIDEO
    Date Cleared
    2001-11-09

    (66 days)

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

    APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE

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

    The CIRCON ACMI USA Series™ APN-2 Flexible Choledochoscope may be used in the biliary tract for diagnostic and therapeutic treatment of ductal stones during laparoscopic cholecystectomy.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Circon Corporation regarding their APN-2™ USA Series™ Flexible Choledochoscope. It is a regulatory approval letter and does not contain information about acceptance criteria or a study proving device performance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory compliance, substantial equivalence determination, and general controls, rather than detailed performance data or clinical study results.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1