# FGE: Stents, Drains And Dilators For The Biliary Ducts

- Device class: 2; regulation: 21 CFR 876.5010; FDA's rule: 510(k) required
- FDA decisions: 478
- 510(k) review time 2021–2025: median 199 days (middle half 127–261)
- Recalls: 432 (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: 9
- 2018: 7
- 2019: 2
- 2020: 4
- 2021: 1
- 2022: 6
- 2023: 6
- 2024: 6
- 2025: 7
- 2026: 8

## Most-cited predicates
- K911581: Palmaz (TM) Balloon-Expandable Stent, Modification (1991), cited by 12
- K112994: Cre Ditatation Ballon (2012), cited by 10
- K021898: Smart Control Nitinol Stent Transhepatic Biliary System (2002), cited by 8
- K964688: Long Medium Palmaz-Schatz Balloon Expandable Stent (1997), cited by 8
- K964119: Wallstent Transhepatic Biliary Endoprosthesis (1997), cited by 8
- K924608: Hydrogel Coated Percuflex (R) Drainage Catheters (1994), cited by 8
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive (2001), cited by 7
- K061231: Wellflex  Biliary RX Stent System (2006), cited by 6
- K961262: Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis (1996), cited by 6
- K073667: Niti-S Biliary Stent (2008), cited by 6

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