The Senhance® Surgical System is the first and only digital laparoscopy platform

Indications for Use: Senhance® Surgical System

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 to be used in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use. The device is restricted to sale by or on the order of a physician.

 

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. 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.

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