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510(k) Data Aggregation

    K Number
    K241005
    Device Name
    Haemostasis Clips
    Manufacturer
    Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd.
    Date Cleared
    2025-01-02

    (265 days)

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

    Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The The Haemostasis Clips are indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking. 2. Hemostasis for: Mucosal/sub-mucosal defects <3cm; Bleeding ulcers; Arteries<2mm; Polyps<1.5cm in diameter; Diverticula in the colon; Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; 4. As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.
    Device Description
    The Haemostasis Clips are sterile devices consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip part. The delivery system consists of a handle assembly and delivery catheter assembly. The delivery system is constructed using stainless steel and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1650mm, 1950mm and 2350mm working lengths. The clip part consists of a stainless steel tightening capsule, movable pin and clip arms. The clip is deployed from the delivery system during use. The hemoclip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.
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