# NWB: Endoscope, Accessories, Narrow Band Spectrum

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 173 days (middle half 118–229)
- Recalls: 8 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2005: 1
- 2006: 1
- 2008: 1
- 2009: 1
- 2010: 1
- 2014: 1
- 2018: 1
- 2022: 2

## Most-cited predicates
- K100584: Evis Exeraii 180 System (2010), cited by 22
- K051645: Evis Exera 160A System (2005), cited by 9
- K062049: Evis Exera II 180 System (2006), cited by 5
- K133538: Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope Olympus Cyf Type VA2, Visera Cysto-NE (2014), cited by 5
- K072957: Evis Exera II 180 System (2008), cited by 4
- K173921: HD-500 Video Endoscope System (2018), cited by 1
- K211882: HD-550 Video Endoscope System (2022), cited by 1

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