# FED: Endoscopic Access Overtube, Gastroenterology-Urology

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 105
- 510(k) review time 2021–2025: median 122 days (middle half 82–149)
- Recalls: 9 (4 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: 1
- 2018: 4
- 2019: 5
- 2020: 4
- 2021: 3
- 2022: 1
- 2023: 3
- 2024: 6
- 2025: 11
- 2026: 6

## Most-cited predicates
- K040836: Disposable Overtube (2004), cited by 10
- K161110: ClearPetra Suction-Evacuation Sheath (2016), cited by 6
- K973500: Bard Endoscopic Overtube (#000307) (1997), cited by 5
- K033954: Shape Locking Endoscopic Overtube (2004), cited by 4
- K052084: Endo-Ease Endoscopic Overtube (2005), cited by 4
- K211301: Pathfinder Endoscope Overtube (2021), cited by 3
- K203165: Disposable Ureteral Access Sheath (2021), cited by 3
- K191415: Pathfinder Endoscope Overtube (2019), cited by 3
- K990775: Ureteral Access Sheath Set (1999), cited by 3
- K993650: Ureteral Access Sheath Set - New Models (1999), cited by 3

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