Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K211309
    Device Name
    endomina system
    Manufacturer
    Endo Tools Therapeutics S.A.
    Date Cleared
    2021-12-07

    (221 days)

    Product Code
    OCW
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Endo Tools Therapeutics S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The endomina® system, composed of a triangulation (endomina® platform) and an instrument for tissue piercing and approximation (TAPES), is intended for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract. The system is to be used on an adult population.
    Device Description
    The endomina® 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 (TAPES). The endomina® system is sterile packaged and designed for single use and is manufactured from various thermoplastic, silicone, 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 stomach. It includes a bendable therapeutic channel meant for the endoscopic tool TAPES. 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. TAPES: TAPES is an instrument intended to be used with the endomina® platform and a flexible endoscope for tissue approximation in the gastrointestinal tract. TAPES is inserted in the bendable arm of endomina®'s platform. TAPES 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.
    Ask a Question

    Page 1 of 1