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510(k) Data Aggregation

    K Number
    K250229
    Device Name
    Dual Action Tissue Closure Device
    Manufacturer
    Micro-Tech (Nanjing) Co., Ltd
    Date Cleared
    2025-09-08

    (224 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K202333,K233772
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract.

    The Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of:

    • Endoscopic marking,
    • Hemostasis for
      • Mucosal/sub-mucosal defects < 5 cm,
      • Bleeding ulcers,
      • Polyps < 1.5 cm in diameter,
      • Diverticula in the colon,
      • Arteries < 2 mm,
    • As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
    Device Description

    The proposed device Dual Action Tissue Closure Device is a sterile, single-use endoscopic clipping device. The 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. It consists of two main components, delivery system and clip component. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10⁻⁶ and placed in a sterility maintenance package to ensure a shelf life of 1 year.

    AI/ML Overview

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