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The Versius Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.

The Versius Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.

The Versius® Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. It consists of the Surgeon Console, a Bedside Unit with a Visualization Arm (Visualization Bedside Unit), one or more Bedside Unit(s) with an Instrument Arm (Instrument Bedside Unit), detachable Surgical Attachments, System Cables and Sterile Drapes. Surgical Attachments comprise Surgical Instruments, Electrosurgery Instruments and an Endoscopic Camera.

The Surgeon interacts with the System through controls and feedback via the Surgeon Console, which includes the Surgeon Console Screen that displays a composite image of the 3D Endoscope Video Feed and a Display Overlay. The Bedside Team access controls and feedback via the Bedside Units and via an Auxiliary Screen, which displays a 2D or 3D version of the Composite Endoscope Feed.

This 510(k) is for the addition of NIR imaging capability, updated software version, additional Surgical Instruments, and material changes in existing Surgical Instruments.

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