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510(k) Data Aggregation

    K Number
    K253781

    Validate with FDA (Live)

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

    (26 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™ 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™ Clip Applier is a disposable clip cartridge contains 10, 16 or 20 implantable titanium clips, and should be used with "Taiwan Surgical" Reusable Clip Applier Handle. 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 sleeves with a fitted converter.

    AI/ML Overview

    N/A

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