# K030107: 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 21, 2003 after 67 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K923119 (1992). 17 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive, Boston Scientific Corp (2001)

## Most influential descendants
- K061231: Wellflex  Biliary RX Stent System (2006), 10 descendants of its own
- K081733: 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890 (2008), 7 descendants of its own
- K083374: Wallflex Biliary RX Partially-Covered Stent System (2009), 6 descendants of its own
- K083627: Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520, M00570530, M00570540 (2009), 6 descendants of its own
- K112543: Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic Covered Stent System (2011), 5 descendants of its own

## Recalls of this device
- Jan 28, 2004 · Not classified · Z-0563-04: Incorrect label states stent covered with 'Permalume Covering', product is uncovered

## Indications for use
The WallstentTM Rx Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K030107
Methodology: https://510kreport.com/methodology