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510(k) Data Aggregation

    K Number
    K253903

    Validate with FDA (Live)

    Device Name
    InnoClip Disposable Clip Applier
    Manufacturer
    Taiwan Surgical Corporation
    Date Cleared
    2025-12-22

    (17 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K202994,K150259
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    InnoClip™ Disposable Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

    Device Description

    The InnoClip™ Disposable Clip Applier consists of a handle piece and 10, 16 or 20 implantable titanium clips. The product line includes two shaft diameters, 10 mm and 5 mm. Titanium clip sizes are 5.5 × 9.0 mm and 5.5 × 11 mm for the 10 mm applier, and 4.6 × 9.1 mm for the 5 mm applier. The applier is designed to be introduced through applicable trocar sleeves, or larger sleeve with a fitted converter.

    AI/ML Overview

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