BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible

    K Number: K211021 · Decision May 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    464
    Applicant Total
    20
    Review Days
    396

    Basic Information

    Device Name
    Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
    K Number
    K211021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Tech (Nanjing) Co., Ltd.
    Date Received
    April 5, 2021
    Decision Date
    May 6, 2022
    Product Code
    FGE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FGE Stents, Drains And Dilators For The Biliary Ducts

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FGE), ordered by most recent decision date.

    Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EGIS Biliary Double Bare Stent (BDB080405)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single-use Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Tornus ES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WallFlex Biliary PLUS RX Stent System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Micro-Tech (Nanjing) Co., Ltd.

    K Number Device Name
    K243388 Disposable Distal Cap
    K243471 Extraction Basket
    K230127 Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
    K222354 Elastic Traction System
    K213060 AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
    K220424 Through the Scope Tracheal Stent System
    K220157 Disposable Hemostatic Closure Clip Device
    K220247 Guidewire Locking Device
    K212748 Disposable Dual Action Tissue Clip
    K211172 Single Use Electrosurgical Knife with Fluid Pump System
    Search all 20 clearances from Micro-Tech (Nanjing) Co., Ltd. →