LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981591
    Device Name
    VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
    Manufacturer
    INTERNATIONAL REGULATORY CONSULTANTS
    Date Cleared
    1998-10-09

    (158 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT

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

    Both the VORTEK and BIOSOFT versions of the ureteral double loop stent are intended for the exact same use as the current silicone ureteral double loop stent. The ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The "flush" ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.

    Device Description

    VORTEK® and BIOSOFT® Ureteral Double Loop Stents

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding VORTEK and BIOSOFT Ureteral Double Loop Stents. It confirms substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1