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

    Tracheal Stent System (Y-Shaped)

    K Number: K212403 · Decision Oct 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    44
    Applicant Total
    41
    Review Days
    89

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Tracheal Stent System (Y-Shaped)
    K Number
    K212403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3720
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Tech (Nanjing) Co., Ltd.
    Date Received
    August 2, 2021
    Decision Date
    October 30, 2021
    Product Code
    JCT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JCT Prosthesis, Tracheal, Expandable

    Similar 510(k) Clearances

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

    Ultraflex™ Tracheobronchial Stent System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Through the Scope Tracheal Stent System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Tracheal Stent System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HANAROSTENT Trachea/Bronchium (CCC)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AEROmini Tracheobronchial Stent System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    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
    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. →