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510(k) Data Aggregation

    K Number
    K252400

    Validate with FDA (Live)

    Date Cleared
    2026-02-13

    (197 days)

    Product Code
    Regulation Number
    876.1500
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The endomina® EZFuse system is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract.

    Device Description

    The endomina® EZFuse system is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract utilizing an endoscope. The system is comprised of a triangulation platform (endomina® platform) and an instrument for tissue piercing and approximation (endomina® EZFuse delivery system and suture). The endomina® EZFuse system is sterile packaged and designed for single use and is manufactured from various thermoplastic, stainless steel materials, biocompatible 3D printing materials and other medical grade materials.

    endomina® platform:
    The endomina® platform can be assembled on a regular flexible endoscope inside the gastrointestinal tract. It includes a bendable therapeutic channel meant for the endoscopic tool endomina® EZFuse suture. This channel can be deployed perpendicular to the axis of the endoscope, thereby ensuring the triangulation, leaving the channel of the endoscope free for other instruments.

    endomina® EZFuse suture:
    Endomina® EZFuse suture is an instrument intended to be used with the endomina® platform and a flexible endoscope for tissue approximation in the gastrointestinal. It is inserted in the bendable arm of endomina®'s platform. It enables piercing and approximation of two, internal tissues with a needle which are then linked by releasing anchors connected with suture. These anchors create a stitch that can then be tightened, generating interrupted stitches in the gastrointestinal tract.

    AI/ML Overview

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