# FDI: Snare, Flexible

- Device class: 2; regulation: 21 CFR 876.4300; FDA's rule: 510(k) required
- FDA decisions: 63
- 510(k) review time 2021–2025: median 247 days (middle half 137–253)
- Recalls: 5 (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)
- 2015: 3
- 2016: 1
- 2017: 1
- 2018: 4
- 2019: 3
- 2020: 2
- 2021: 1
- 2022: 4
- 2023: 1
- 2026: 1

## Most-cited predicates
- K172729: Polypectomy Snare (2018), cited by 4
- K955650: Olympus SD Series Snares (1996), cited by 4
- K941750: Proposed Trademan Microvasive Polypectomy Snares (1994), cited by 3
- K131700: Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use Polypectomy Snares (2013), cited by 3
- K943935: Gip/Medi-Globe Polypectomy Snares (1995), cited by 3
- K950496: Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories (1995), cited by 2
- K050294: Cook Ireland Sonnet Polypectomy Snare (2005), cited by 2
- K133987: Captivator II,Single-Use Polypectomy Snares (2014), cited by 2
- K992477: Rotosnare (1999), cited by 2
- K172758: Rotatable Snares, Non-Rotatable Snares (2018), cited by 2

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