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510(k) Data Aggregation

    K Number
    K252271
    Device Name
    Hemoclip
    Manufacturer
    Hangzhou AGS MedTech Co.,Ltd.
    Date Cleared
    2025-11-12

    (114 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K221713,K211787
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The hemoclip is 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
    3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.
    4. As a supplementary method, closure of GI tract luminal perforations<20mm that can be treated conservatively.
    Device Description

    Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Plastic Coated Spring Tube / Spring Tube and Handle assembly. EO Sterilization and use for single use only.

    AI/ML Overview

    N/A

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