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510(k) Data Aggregation

    K Number
    K232969
    Device Name
    Disposable Hemostatic Clips
    Manufacturer
    Ningbo Xinwell Medical Technology Co., Ltd
    Date Cleared
    2024-06-07

    (260 days)

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

    Ningbo Xinwell Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Hemostatic Clips is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations only via a straight or side viewing flexible endoscope for the purpose of : 1) Endoscopic marking; 2) Hemostasis for: A) Mucosal/sub-mucosal defects < 3cm. B) Bleeding ulcers. C) Polyps < 1.5cm in diameter. D) Diverticula in the colon. E) Arteries < 2 mm. F) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. 3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively 4) Anchoring to affix jejunal feeding tubes to the wall of the small bowel
    Device Description
    The proposed device is consisted of a clip section. The delivery section. The delivery section include: slide bar, slip ring, protective sleeve, rotation head, coated spring tube, slip ring holder, traction assembly, connecting tube, decoupled piece, decoupled shrapnel, rotation sleeve. And the clip section include: clip, sliding block, shaft and rocker arm. The clip is made of stainless steel. The clip can be opened and closed more than five times prior to deployment, aiding in repositioning of the lesion site. The proposed device is available in single ring and three ring models, and each case is divided into rotatable and non-rotatable clip. The effective length of the proposed device includes 1250mm, 1650mm, 2350mm and the opening width is 9mm, 11mm. 13mm and 16mm. The proposed devices are provided in sterile and single use.
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    K Number
    K232200
    Device Name
    Disposable Injection Needles
    Manufacturer
    Ningbo Xinwell Medical Technology Co., Ltd
    Date Cleared
    2024-04-12

    (262 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Xinwell Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
    Device Description
    The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.The Disposable Injection Needles are consist of needle tube, inner tube, outer tube, protective sleeve, booster tube, handle, limitation ring, buckle and conical connector. The needle tube and booster tube are made of 06Cr19Ni10. The inner tube are made of PP.The handle, limitation ring, buckle and connector are made of ABS. The diameter of the outer tube is available in two specifications, respectively are 1.8mm and 2.3mm. There are five specifications for the working length of the outer tube, respectively are 1200mm,1800mm,2000mm and 2300mm. There are three specifications for outer diameters of needle tube, respectively are 21G, 23G and 25G. Five specifications for lengths of needle tube, respectively are 4mm, 5mm, 7mm and 8mm. The device is sterilized by ethylene oxide. The shelf life is 3 years. The inner, middle and transportation packaging ways respectively are sealed pouch, box and carton.The corresponding product quantities is 1 pc per bag, 10 pcs per box and 5 boxes per carton.
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