# FDF: Colonoscope And Accessories, Flexible/Rigid

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 115
- 510(k) review time 2021–2025: median 168 days (middle half 76–224)
- Recalls: 12 (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: 4
- 2018: 7
- 2019: 4
- 2020: 4
- 2021: 3
- 2022: 5
- 2023: 6
- 2024: 2
- 2025: 4
- 2026: 5

## Most-cited predicates
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I (2000), cited by 15
- K131855: Pentax Video Colonoscopes (EC Family) (2014), cited by 8
- K951574: EC-3800L, Video Colonoscope (1996), cited by 8
- K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 (2009), cited by 7
- K032688: Colonosight Model 510B (2004), cited by 6
- K112680: Evis Exera Iii Video System (2012), cited by 5
- K131780: Evis Exera Iii Video System (2013), cited by 4
- K121582: Invendo C25 Colonoscopy System (2012), cited by 4
- K230332: Ambu® aScope™ Colon; Ambu® aBox™ 2 (2023), cited by 4
- K070622: Neoguide Endoscopy System (2007), cited by 4

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