# K261573: Endoscope Holder (182214)

- Pathway: 510(k) (Traditional)
- Applicant: Aktormed GmbH
- Decided: Jul 20, 2026 after 69 days
- Product code: QZB (Software Controlled Endoscope And Instrument Holder)
- 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: 7 generations back to K931783 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233312: SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894, Aktormed GmbH (2024) Summary page 5.

## Indications for use
For the ENDOSCOPE HOLDER as a component of the SOLOASSIST IIS the indications for use of the SOLOASSIST IIS applies. The intended use of the SOLOASSIST IIS is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The SOLOASSIST IIS is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST IIS 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 IIS are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons and urologists.

Source page: https://510kreport.com/device/K261573
Methodology: https://510kreport.com/methodology