# FBN: Choledochoscope And Accessories, Flexible/Rigid

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 43
- 510(k) review time 2021–2025: median 190 days (middle half 162–244)
- Recalls: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 1
- 2015: 1
- 2016: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2023: 4
- 2024: 2
- 2025: 3
- 2026: 3

## Most-cited predicates
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System (2006), cited by 7
- K142922: SpyGlass DS Direct Visualization System (2015), cited by 4
- K912120: Urf-P2 Ureterorenofiberscope/Choledochofiberscope (1991), cited by 4
- K962172: Flexible Mini-Fiberscopes (1996), cited by 2
- K051886: Olympus Choledochoscope, Model XCHF-BP160F (2005), cited by 2
- K904799: CHF-B20 Choledochoscope (1991), cited by 2
- K181439: SpyGlass DS and DS II Direct Visualization System (2018), cited by 2
- K080586: Olympus XCHF Type B180Y1 (2008), cited by 2
- K221784: Single-use Video Pancreaticobiliary Scope, PB Digital Controller (2023), cited by 2
- K081456: Olympus CHF Type V (2008), cited by 2

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