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    K Number
    K253734

    Validate with FDA (Live)

    Device Name
    Taurus Clip
    Manufacturer
    Taurus Endoscopy
    Date Cleared
    2026-03-12

    (108 days)

    Product Code
    PKL
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    18 - 999
    Reference & Predicate Devices
    K192722,K222503
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K192722

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Taurus Clip is indicated for placement within the Gastrointestinal (GI) tract of adult patients for the purpose of:

    1. Endoscopic marking

    2. Hemostasis for:

      • Mucosal/sub-mucosal defects < 3 cm
      • Bleeding ulcers
      • Arteries < 2 mm
      • Polyps < 1.5 cm 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; and

      Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus

    4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

    Device Description

    The Taurus Clip is a sterile, single-use endoscopic clip designed for closure, hemostasis, endoscopic marking, and anchoring. The Taurus Clip is designed to be compatible with forward-viewing endoscopes with working channels equal to or greater than 2.8mm.

    The Taurus Clip Device consists of two main components: one preloaded titanium Clip Implant and a flexible delivery system, referred to as the "Applier".

    The Clip Implant can be used to manipulate the mucosal tissue of the GI tract as desired and then applied (deformed and released) with the handle once in place. The Applier is removed after clip deployment.

    AI/ML Overview

    N/A

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