# FDA: Enteroscope And Accessories

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 115 days (middle half 77–161)
- 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)
- 2006: 2
- 2008: 1
- 2015: 1
- 2019: 2
- 2020: 1
- 2021: 1
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K040048: Fujinon Double Balloon Enteroscopy System (2004), cited by 10
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (2015), cited by 7
- K183032: FUJIFILM Double Balloon Endoscope EI580BT (2019), cited by 2
- K071254: Small Intestinal Videoscope System (2008), cited by 2
- K060923: Naviaid Bge Device, Model 21-001 (2006), cited by 1
- K031256: Xsif-1TQ140A Small Intestinal Videoscope (2003), cited by 1
- K993704: Gastro-Intestinal System EN-410WM (2000), cited by 1
- K213195: Balloon BS-3 (2021), cited by 1
- K060235: Endo-Ease Endoscopic Overtube (2006), cited by 1
- K223295: Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (2023), cited by 1

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