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

    Esophageal Stent System

    K Number: K172813 · Decision May 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    58
    Applicant Total
    41
    Review Days
    242

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    Basic Information

    Device Name
    Esophageal Stent System
    K Number
    K172813
    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
    September 18, 2017
    Decision Date
    May 18, 2018
    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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    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
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