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The SimpleStitch Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue (e.g., closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks).

The SimpleStitch Suturing System ("SimpleStitch SS") is a sterile, single patient-use device that enables endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract using a flexible endoscope. The system includes the following components: SimpleStitch Suture Device, SimpleStitch Suture Cartridge, and SimpleStitch Suture Cinch. The SimpleStitch SS is designed for compatibility with single-channel endoscopes (gastroscopes and colonoscopes) with a minimum working channel inner diameter of 2.8mm. During use, the suturing device/suture cartridge is mounted to the endoscope's exterior; the cinching device goes through the endoscope's working channel. The SimpleStitch SS is available with a USP 2-0 and USP 0 nonabsorbable polyester suture. Tissue is secured using a cinch anchor once tissue approximation is complete.

The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.

The MaxTack™ Motorized Fixation Device is a single-use, sterile device that contains 30 absorbable tacks, preloaded into a standard shaft. The device is designed for introduction and use through a 5 mm or larger cannula. The device's tacks are constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The first 25 tacks are dyed with D&C Violet No. 2. The last 5 tacks are dyed with D&C Green No. 6. to serve as an indicator of low tack count to the user. The distal end of the shaft has a mesh manipulation/grip feature that may be used to facilitate positioning of the mesh. The device is intended for use in a sterile operating room environment in surgical procedures where fixation of prosthetic material, such as mesh, to soft tissues is indicated. This device is designed, tested, and manufactured for single patient use only. Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving fixation devices prior to employing this device.

The Mediclose™ System is a single-use indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.

The Mediclose™ System is an Automatic Trocar Closure (ATC) device supplied with one or more Mediclose™ Adaptors, supplied sterile for single use. The combination of the Mediclose™ Device and one Mediclose™ Adaptor results in a minimally invasive surgical system which aids surgeons in closing trocar wounds following a laparoscopic procedure. In laparoscopic surgery, trocars are used to gain access to the body in a minimally invasive way. This means that these procedures are performed through incisions of approximately 12 mm, compared to traditional open surgery which needs a large wound across the abdomen. The Mediclose™ Device is available in one size and configuration, designed for single-handed use, to which each of three Mediclose™ Adaptors can be fitted, at the user's option, depending on the make/model of trocar being used. The Mediclose™ System is intended to pass a suture through the soft-tissue laver (fascia) of a trocar wound after laparoscopic surgery. This is done with the end-goal of closing the trocar-induced wound by pulling needles through the fascia and subsequently closing the wound. The Mediclose™ System has two items: The Mediclose™ Device, which incorporates the suture and needle set; The Mediclose™ Adaptor, three color-coded models are available separately from the Mediclose™ . Device which are compatible with a specific brand/model of 12 mm trocar sleeves that are legally cleared for marketing in the USA, viz: Ethicon EndoPath Covidien VersaOne Applied Medical Kii The Mediclose™ Device also contains a needle-suture set manufactured by Assut Europe composed of two straight cylindrical needles attached to Glicofil Lac, a braided, coated, violet PGLA absorbable suture. The suture and needles are mounted into the device at the time of manufacture, making it ready to use upon opening the packaging.

The OverStitch NXT Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch NXT Endoscopic Suturing System (ESS) and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix or NXT Tissue Helix Pro, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials. The OverStitch NXT ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using polyester medical tape for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel. The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.

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.

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.

The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.

The Anchora Su2ura® Approximation Device is a sterile single use device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue. The device is a 5mm single-use endoscopic suturing device loaded with threaded anchors. It is designed to deploy up to 19 anchors by a trigger action of the handle of the delivery system. After deployment, each anchor is anchored within the tissue in which it was deployed. After deployment of 2 or more anchors, the suture that passes between the anchors can be tightened to pull the anchors toward each other and approximate the tissue. The delivery system consists of a plastic handle and a 36-cm stainless steel shaft. The handle includes a Trigger, a Knob, and a Toggle Button. A Cap can be added at the distal edge of the Shaft to advance extracorporeal suture knots. The anchors can be deployed in single-stitch or running- stitch configuration. The device deploys the anchors through a needle with an outer diameter of 2.1 mm, available in two lengths: 5 mm and 9 mm protrusion. The Anchor is advanced outside of the needle by a Pushrod. Each anchor, made of stainless steel, is threaded with an off-the-shelf UHMWPE suture manufactured by Teleflex Medical. The device provides the anchors already threaded on this suture. The device is sterile packaged and designed for single use only. The device is manufactured from medical grade materials (mainly plastics and stainless steels).

The OverStitch Sx Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

OverStitch™ Sx Endoscopic Suturing System and The accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials. The OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using thermoplastic polyurethane straps for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel. The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.

The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

The AbClose™ - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by folding the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.

The OverStitch Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The OverStitch Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.