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The Endo Wrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X Surgical System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000 and da Vinci Surgical System, Model IS4200) is intended to 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, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci X/Xi 8 mm monopolar scissors instrument (470179) is used in conjunction with its intended surgical robot for cutting, cauterizing, coagulation, manipulating and blunt dissue. This instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axis of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory. Endo Wrist Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for greater precision in a minimally invasive environment. EndoWrist instruments, in conjunction with the applicable surgical robot, are designed to support rapid and precise suturing, dissection, and tissue manipulation in surgical procedures. The design, materials, and intended use of the Reusable Surgical Instruments, after an additional ten (10) reuse cycles, are substantially equivalent to the predicate device in form, fit, and function. The reusable device is identical to the predicate device in that the same standard mechanicals, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.

The EndoWrist ProGrasp Forceps instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System and the Intuitive Surgical IS3000 da Vinci Si Surgical System for grasping and manipulation of tissue. The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The subject device is a remanufactured 420093 ProGrasp Forceps with a grasping end effector to be used with the Intuitive Surgical da Vinci Endoscopic Instrument Control System (IS 2000 / IS 3000) for grasping and manipulating tissue during and endoscopic procedure. The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, dinical applications. patient population, or method of operation.

The EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue. The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral procedures restricted to benign and malignant tumors classified as Tl and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by sicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. The 8mm Monopolar Scissors of this submission are for use only with the Intuitive Si System (Endoscopic Instrument Control System),

The 8mm Monopolar Curved Scissors Instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile. 8mm Monopolar Curved Scissor Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for grecision when operating in a minimally invasive environment. EndoWrist 8mm Monopolar Curved Scissor Instruments, when used with the IS3000 system, are designed to support rapid and precise suturing, dissection and tissue manipulation in surgical procedures.