# FBK: Endoscopic Injection Needle, Gastroenterology-Urology

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 89
- 510(k) review time 2021–2025: median 184 days (middle half 142–245)
- Recalls: 41 (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)
- 2017: 3
- 2018: 2
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 6
- 2023: 3
- 2024: 4
- 2025: 3
- 2026: 2

## Most-cited predicates
- K022484: Cook Injection Needle (2002), cited by 6
- K982890: Advanced Uroscience Injection Needle (1998), cited by 5
- K150434: Injection Needle (2015), cited by 4
- K941305: Wilson-Cook Variable Length GI Injection Needle (1994), cited by 3
- K061222: Injectra Injection Needle (2006), cited by 3
- K171454: Interject Injection Therapy Needle Catheter (2017), cited by 3
- K210917: Single Use Injection Needle (2021), cited by 3
- K190032: Disposable Sclerotherapy Needle (2020), cited by 2
- K011484: Olympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 (2001), cited by 2
- K213914: Injection Needle (2022), cited by 2

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