LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K031238
    Device Name
    VARICES NEEDLE
    Manufacturer
    SCANDIMED. A.S.
    Date Cleared
    2004-10-04

    (535 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Varices Needle is used to inject sclerotherapy agent into varices in the esophagus and colon, via an endoscope using direct visualization. The Varices Needle is intended for single use only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "Varices Needle." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the technical documentation submitted by the manufacturer, not in the FDA approval letter itself, which primarily confirms substantial equivalence to a predicate device for market clearance.

    Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1