510(k) · Cleared
ClearedEndoscope Holder (182214)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aktormed GmbH · QZB Software Controlled Endoscope And Instrument Holder
Cleared on Jul 20, 2026 as substantially equivalent to K233312 (Aktormed GmbH, 2024) after a 69-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Jul 20, 2026
- Review
- 69 days
- Class
- Class II
- Product code
- QZB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K931783 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 6 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 5 generations backK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
- 4 generations backK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
- 3 generations backK171947 Soloassist IIAktormed GmbH · 2018
- 2 generations backK200473 SoloAsisst II, Voice ControlAktormed GmbH · 2020
- 1 generation backK233312 SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426)…Aktormed GmbH · 2024
- This deviceK261573 Endoscope Holder (182214)Aktormed GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −6 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −5 | K963126 | Aesop System and Accessories | Computer Motion, Inc. | 1997 | — |
| −4 | K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | 1997 | — |
| −3 | K171947 | Soloassist II | Aktormed GmbH | 2018 | — |
| −2 | K200473 | SoloAsisst II, Voice Control | Aktormed GmbH | 2020 | — |
| −1 | K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip… | Aktormed GmbH | 2024 | — |
| 0 (this device) | K261573 | Endoscope Holder (182214) | Aktormed GmbH | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QZB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QZB device
- #1 K242323 Maestro System (REF100)score 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice…Summary page 5…r 876.1500 Product Code(s) QZB | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233312 UNIVERSAL JOINT, ENDOSCOPE CLAMP, TENSION SLEEVE | | QzB D5, TENSION SLEEVE D10 Device Description Summary 21 CFR 807.92(a)(4) T… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All QZB devicesQZB Software Controlled Endoscope And Instrument Holder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QZB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QZB
Too few QZB 510(k)s in any year since 2007 to give a median.
Recalls per year · QZB
No recall names QZB since 2007.
Adverse event reports per year · QZB
No MAUDE report names QZB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (146 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261573: Endoscope Holder (182214).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261573
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026