# QZB: Software Controlled Endoscope And Instrument Holder

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 220 days (middle half 154–267)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K242323: Maestro System (REF100) (2025), cited by 1
- K233312: SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 (2024), cited by 1

Source page: https://510kreport.com/product-code/QZB
Data by year (CSV): https://510kreport.com/product-code/QZB.csv