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510(k) Data Aggregation

    K Number
    K250643
    Date Cleared
    2025-11-20

    (261 days)

    Product Code
    Regulation Number
    878.4300
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

    Device Description

    The Disposable polymer ligation clips includes Polymer Clips and Multiple polymer clips. The devices are sterilized by EO, single-use, non-absorbable, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The Disposable polymer ligation clips are compatible with the reusable, non-sterile Clip appliers which are made by Kangji. The clips are placed around the tissue and closed with the grip of a clip applier. These clips are made of medical grade acetyl homopolymer and supplied in different sizes and packaged in different clip quantity.

    Polymer Clips are housed in a colored cartridge which is consist of base and platen. The clips shall be placed and fired in clip applier one by one. Polymer Clips are available in four sizes: M, ML, L, XL.

    Multiple polymer clips (model: KJ-JZJDML, KJ-JZJDL, KJ-JZJDXL) are available in 3 sizes (ML, L, XL), housed in a colored cartridge and has 3 clips which can be placed in clip applier in one time and fired constantly totally 3 times.

    Multiple polymer clips (except model: KJ-JZJDML, KJ-JZJDL, KJ-JZJDXL) are available in ML and L size, housed in a striped cartridge. The cartridge which contains 5-15 clips will be placed in clip applier. The clips will be delivered individually advance after each firing.

    AI/ML Overview

    N/A

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