# ESW: Prosthesis, Esophageal

- Device class: 2; regulation: 21 CFR 878.3610; FDA's rule: 510(k) required
- FDA decisions: 60
- 510(k) review time 2021–2025: median 125 days (middle half 44–199)
- Recalls: 35 (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)
- 2013: 2
- 2016: 1
- 2018: 2
- 2019: 1
- 2020: 1
- 2021: 4
- 2022: 1
- 2024: 4
- 2025: 3
- 2026: 1

## Most-cited predicates
- K032930: Ultraflex Esophageal NG Stent System (2003), cited by 7
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 (2009), cited by 6
- K003173: Aspire Covered Stent and Delivery Catheter (2001), cited by 5
- K080782: Niti-S Esophageal Stent (2009), cited by 5
- K123205: Esophageal TTS Stent (2013), cited by 4
- K030559: Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System (2003), cited by 4
- K051621: Endoventions Alimaxx-E Esophageal Stent System (2005), cited by 4
- K012883: Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System (2001), cited by 4
- K073266: Wallflex Partially Covered Esophageal Stent System (2008), cited by 4
- K072094: Choostent (2008), cited by 3

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