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The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast, mouth, scalp, extremities, and in open lymphatic surgery of the extremities. The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the surgeon. The System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.

Symani is designed to provide surgeons with increased precision while leveraging the surgeon's own surgical experiences. The Symani Surgical System consists of three components, the CMM, Console, and Instruments, with selectable scaling factors (between 7x to 20x) to improve motion control and scale down any physiological tremor of the operator in a similar fashion to conventional robotic-assisted surgical device (RASD) systems, and the instruments with wristed end-effectors to improve dexterity for tissue manipulation and suturing.

The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities. The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the surgeon. The System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.

Symani is designed to provide surgeons with increased precision while leveraging the surgeon's own surgical experiences. The Symani Surgical System consists of three components, the CMM, Console, and Instruments, with selectable scaling factors between 7x to 20x to improve motion control and scale down any physiological tremor of the operator in a similar fashion to conventional robotic-assisted surgical device (RASD) systems, and the instruments with wristed end-effectors to improve dexterity for tissue manipulation and suturing. The subject device has the same intended use and indications for use, and same technological characteristics as the predicate device, DEN230032. The Supermicro Needle Holder Suture Cut instrument has been added to the NanoWrist Instruments' portfolio.

The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis. suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities. The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.

The Symani Surgical System is designed for open microsurgery procedures, featuring articulated and interchangeable instruments. The surgeon manipulates the Master Controllers, which in turn drive the articulated (wristed) robotic Instruments at the operating table/site, replicating and scaling down the surgeon movements using a chosen scaling factor. Symani is used in combination with conventional surgical microscopes, either optical or digital. Symani is composed of three main components (Figure 1): - The Console, which is a reusable equipment and not sterile; . - The Cart with Macropositioner and two Micromanipulators, which is a reusable equipment . and not sterile: and - . Two articulated Instruments, which are single-use and terminally sterilized via ethylene oxide