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