# EYB: Catheter, Ureteral, Gastro-Urology

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 28
- Recalls: 4 (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)
- 2003: 2
- 2004: 1
- 2005: 1
- 2009: 1
- 2010: 1
- 2014: 1
- 2017: 1
- 2018: 2
- 2019: 3
- 2020: 1

## Most-cited predicates
- K962004: AQ Hydrophilic Urological Catheters (1996), cited by 2
- K950300: Bard Flexible Tip Ureteral Catheter (1995), cited by 2
- K923729: Ureteral Catheter (1993), cited by 2
- K021856: Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX (2002), cited by 2
- K171043: Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (2017), cited by 1
- K930483: Ureteral Catheter (1993), cited by 1
- K033368: Fossa Ureteral Open Lumen Stent (2003), cited by 1
- K032521: Bard Dual Lumen Ureteral Catheter (2003), cited by 1
- K043581: Dual Lumen Catheter (2005), cited by 1
- K020577: Applied Ureteral Catheter (2002), cited by 1

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