# K171947: Soloassist II

- Pathway: 510(k) (Traditional)
- Applicant: Aktormed GmbH
- Decided: Sep 21, 2018 after 449 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931783 (1993). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972699: Aesop 3000 System and Accessories, Computer Motion, Inc. (1997) Summary page 5.

## Most influential descendants
- K200473: SoloAsisst II, Voice Control (2020), 2 descendants of its own
- K233312: SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 (2024), 1 descendant of its own
- K261573: Endoscope Holder (182214) (2026), 0 descendants of its own
- K223673: Surgeon Controlled Arm (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K171947
Methodology: https://510kreport.com/methodology