# EWY: Mediastinoscope, Surgical

- Device class: 2; regulation: 21 CFR 874.4720; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 270 days (middle half 269–272)
- 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)
- 1991: 2
- 1993: 1
- 1995: 1
- 1997: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2021: 1
- 2022: 1
- 2026: 1

## Most-cited predicates
- K954910: Karl Storz Optical Mediastinoscope (1995), cited by 4
- K971166: Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece (1997), cited by 2
- K141622: Illuminated Mediastinoscope (2015), cited by 2
- K160171: Illuminated Mediastinal Access Port (2016), cited by 1
- K930215: Flexible Trocar Tubes (1993), cited by 1
- K213194: HD Mediastinoscope (2022), cited by 1

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