US Indication:

The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and
retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures, laparoscopic gynecological surgery, and laparoscopic urological surgery. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating
room environment in accordance with the instructions for use.

Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.

Eye trackers supplied by Tobii.

The Senhance System was developed under a license of the European Commission Joint Research Centre.

 

EU Indication:

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, suturing, mobilization, retraction, and sealing of vessels up to and including 5 mm in diameter in laparoscopic and thoracoscopic surgery. The system is indicated for adult and pediatric use. For pediatric use, the system is limited to laparoscopic surgery. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use. Use of the device is limited to patients with a weight equal to or above 10 kg, who are suitable to be subjected to a conventional endoscopic technique. 

Unless otherwise indicated, the legal manufacturer for CE purposes is Asensus Surgical Italia Srl (Notified Body identification number for Class IIa and IIb devices:1936).

The legal manufacturer for CE purposes of bipolar instruments is Günter Bissinger Medizintechnik GmbH.

Eye trackers supplied by Tobii.

The Senhance System was developed under a license of the European Commission Joint Research Centre. 

 

Japan Indication:

The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, suturing, mobilization, and retraction in laparoscopic surgery. The system is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.   

Four manipulator arm configurations are only available in CE Markets and Japan.

Eye trackers supplied by Tobii.

The Senhance System was developed under a license of the European Commission Joint Research Centre.