# FFL: Dislodger, Stone, Basket, Ureteral, Metal

- Device class: 2; regulation: 21 CFR 876.4680; FDA's rule: 510(k) exempt
- FDA decisions: 52
- Recalls: 8 (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)
- 1994: 5
- 1995: 4
- 1996: 2
- 1997: 2
- 2002: 1
- 2005: 1
- 2008: 1
- 2011: 1
- 2017: 1
- 2019: 1

## Most-cited predicates
- K052048: Accordion (2005), cited by 3
- K863081: 4-Wire (Carson) Stone Extractor (1986), cited by 2
- K851965: Wilson-Cook Stone Extractor (1985), cited by 2
- K860269: Van-Tec Deflecting Loop Retriever (1986), cited by 1
- K831875: Balloon Dilation Helical Stone Extract (1983), cited by 1
- K082803: Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015 (2008), cited by 1
- K864874: Segura Dretler Basket (1987), cited by 1
- K935721: Stone Extractor (1994), cited by 1
- K871779: Helical Stone Basket (Disposable) (1987), cited by 1
- K871777: Van-Tec Reusable Helical Stone Basket (1987), cited by 1

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