# FGB: Ureteroscope And Accessories, Flexible/Rigid

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 120
- 510(k) review time 2021–2025: median 174 days (middle half 93–228)
- Recalls: 21 (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: 2
- 2018: 4
- 2019: 2
- 2020: 2
- 2021: 3
- 2022: 5
- 2023: 8
- 2024: 16
- 2025: 17
- 2026: 9

## Most-cited predicates
- K172098: Medical Video Endoscope System (2017), cited by 13
- K153049: LithoVue System (2015), cited by 7
- K131369: Flexible Video-Uretero-Renoscope System (2013), cited by 5
- K141250: Flexible Video-Uretero-Renoscope System (2014), cited by 4
- K940464: Karl Storz Uretero-Renoscope/Ureterscope (1994), cited by 3
- K033651: Olympus Video Ureteroscope, NTSC (2004), cited by 2
- K011849: Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series (Mro-733) Ureteros (2001), cited by 2
- K052044: Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL (2005), cited by 2
- K970427: Ksea Uretero-Reno-Fiberscope and Nephro-Fiberscope (1997), cited by 2
- K142556: Flexible Video-Uretero-Choledochoscope System (2014), cited by 2

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