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

    Segmented Esophageal Stent System

    K Number: K182910 · Decision May 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    58
    Applicant Total
    41
    Review Days
    224

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    Basic Information

    Device Name
    Segmented Esophageal Stent System
    K Number
    K182910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Tech (Nanjing) Co., Ltd.
    Date Received
    October 17, 2018
    Decision Date
    May 29, 2019
    Product Code
    ESW
    Advisory Committee
    General, Plastic Surgery
    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
    ESW Prosthesis, Esophageal

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

    K Number Device Name
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    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
    K221784 Single-use Video Pancreaticobiliary Scope, PB Digital Controller
    K222354 Elastic Traction System
    K213060 AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
    K220424 Through the Scope Tracheal Stent System
    Search all 41 clearances from Micro-Tech (Nanjing) Co., Ltd. →