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Regulatory informations


SOLOASSIST II and Voice Control

 

EU
SOLOASSISTII is CE marked as class I product according to the Medical Device Regulation (EU) 2017/745.
SOLOASSISTII is a robotic computer driven system. The intended use is to hold and position a rigid laparoscope / endoscope for the minimally invasive intervention in abdominal surgery, thoracic surgery, urology, gynecology or cardiac surgery. The SOLOASSIST is used primarily by the surgeon performing the operation.

 

US
SOLOASSISTII is 510(k) cleared by FDA.
The intended use of the SOLOASSISTII is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSISTII is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the SOLOASSISTII are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.

 


ENDOFIX exo

 

EU
ENDOFIX EXO is CE marked as class I product according to the Medical Device Regulation (EU) 2017/745.
ENDOFIX EXO is a manual operated holding arm. The intended use is to hold and position a rigid laparoscope/ endoscope for the minimally invasive intervention in ENT and Scull Base Surgery or to hold and position an exoscope for visualization during open surgeries. The Endofix EXO is used primarily by the surgeon performing the operation.

US
ENDOFIX EXO is not available for sale in the US.