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

    Disposable Dual Action Tissue Closure Device

    K Number: K233772 · Decision Mar 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    5
    Review Days
    116

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    Basic Information

    Device Name
    Disposable Dual Action Tissue Closure Device
    K Number
    K233772
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mirco-Tech (Nanjing) Co., Ltd.
    Date Received
    November 24, 2023
    Decision Date
    March 19, 2024
    Product Code
    PKL
    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
    PKL Hemostatic Metal Clip For The Gi Tract

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    Dual Action Tissue Closure Device

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    View all

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

    K Number Device Name
    K260262 Injection Needle
    K253832 Dilation Balloon Catheter
    K254153 Single-use Video Scope; PB Digital Controller
    K253139 Disposable Distal Cap