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510(k) Data Aggregation
(224 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, and general thoracoscopic surgical procedures. The system is also indicated for selected thoracoscopically-assisted cardiac surgical procedures using the non-force feedback instruments. The system is indicated for adult use.
The da Vinci Surgical System (IS5000) is a software-controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Side Console (Console), a Patient Side Cart (Robot), and a Vision System Cart (Tower) and is used with an Endoscope, EndoWrist Instruments, and Accessories.
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