# GCA: Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

- Device class: 2; regulation: 21 CFR 876.5010; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 171 days (middle half 113–217)
- Recalls: 1 (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)
- 2004: 1
- 2007: 1
- 2017: 1
- 2018: 2
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K170292: Tri-Ex Extraction Balloon With Multiple Sizing (2017), cited by 3
- K040129: Tri-EX Extraction Balloon with Multiple Sizing (2004), cited by 2
- K200173: Stone Retrieval Balloon (2020), cited by 2
- K063677: Fusion Quattro Extraction Balloon XL (2007), cited by 2
- K173414: Advance Biliary Balloon Catheter (2018), cited by 1
- K910917: Cathlab Silicone Biliary Balloon Catheter (1991), cited by 1
- K011018: Taut Balloon Catheter, Model 50640 (2001), cited by 1
- K210660: Stone Retrieval Balloon Catheter (2021), cited by 1
- K920342: Bard Stone Removal Balloon Catheter (1992), cited by 1
- K953951: Wilson-Cook Triple Lumen Balloon Stone Extractor (1995), cited by 1

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