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510(k) Data Aggregation

    K Number
    K233772
    Device Name
    Disposable Dual Action Tissue Closure Device
    Manufacturer
    Mirco-Tech (Nanjing) Co., Ltd.
    Date Cleared
    2024-03-19

    (116 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mirco-Tech (Nanjing) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only. The Disposable Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking: 2. Hemostasis for: a.Mucosal/sub-mucosal defects < 5 cm, b.Bleeding ulcers, c.Polyps < 1.5 cm in diameter, d.Diverticula in the colon, e. Arteries < 2 mm, 3. As a supplementary method. closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
    Device Description
    The proposed device Disposable Dual Action Tissue Closure Device is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression, manipulation of tissue in the gastrointestinal tract. It consists of two main components, delivery system and clip assembly. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
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