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

    Single-use Video Pancreaticobiliary Scope, PB Digital Controller

    K Number: K221784 · Decision Feb 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    42
    Applicant Total
    41
    Review Days
    240

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    Basic Information

    Device Name
    Single-use Video Pancreaticobiliary Scope, PB Digital Controller
    K Number
    K221784
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Tech (Nanjing) Co., Ltd.
    Date Received
    June 21, 2022
    Decision Date
    February 16, 2023
    Product Code
    FBN
    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
    FBN Choledochoscope And Accessories, Flexible/Rigid

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

    K Number Device Name
    K252492 Visualized Access and Delivery Catheter; PB Digital Controller
    K251692 Advanced Tissue Resection Device
    K250229 Dual Action Tissue Closure Device
    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
    Search all 41 clearances from Micro-Tech (Nanjing) Co., Ltd. →