# FAJ: Cystoscope And Accessories, Flexible/Rigid

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 92
- 510(k) review time 2021–2025: median 143 days (middle half 81–206)
- Recalls: 9 (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)
- 2017: 2
- 2018: 2
- 2019: 3
- 2020: 2
- 2021: 3
- 2022: 5
- 2023: 5
- 2024: 9
- 2025: 8
- 2026: 5

## Most-cited predicates
- K193095: Ambu aScope 4 Cysto (2020), cited by 10
- K093665: Endo Smartcap (2009), cited by 9
- K040215: Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System (2004), cited by 5
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA (2002), cited by 5
- K980401: Flexible Fiberscopes and Accessories (1998), cited by 3
- K072180: Vision-Sciences CST-5000 Video Cystoscope with Endosheath System (2007), cited by 3
- K993041: Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary Equipment (2000), cited by 3
- K053560: Modified Endosheath System for Vsi Flexible Cystoscope (2006), cited by 2
- K030960: Ecn Electronic Video Cystonephroscope (2003), cited by 2
- K042225: Acmi Invisio Icn, Models Icn-0564 and Icn-0565 (2004), cited by 2

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