# NUJ: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 172 days (middle half 80–279)
- Recalls: 16 (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
- 2014: 1
- 2015: 2
- 2016: 5
- 2017: 3
- 2018: 7
- 2019: 1
- 2022: 2
- 2023: 1
- 2024: 1

## Most-cited predicates
- K123096: Reprocessed Vessel Sealer (2013), cited by 1
- K012598: Reprocessed Laparoscopic Electric Instuments (2001), cited by 1
- K220411: Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (2022), cited by 1
- K043198: Vanguard Reprocessed Arthroscopic Wands (2005), cited by 1

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