Regulatory informations

SOLOASSIST II

EU
SOLOASSIST II is CE marked as class I product according to the Medical Device Directive 93/42/ECC.

SOLOASSIST II 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
SOLOASSIST II is 510(k) cleared by FDA.
The intended use of the SOLOASSIST II 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, SOLOASSIST II 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 SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.

Voice Control

EU
VOICE CONTROL is CE marked as class I product according to the Medical Device Directive 93/42/ECC.

VOICE CONTROL is an accessory for SOLOASSIST II. The intended use is the input of voice commands for control of SOLOASSIST II.
US
Voice Control for SOLOASSIST is not available for sale in the US

Endofix EXO

EU
Endofix EXO is CE marked as class I product according to the Medical Device Directive 93/42/ECC.
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

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