# K914277: Wallstent (R) Trans Biliary Endo W/Unistep Deliv SY

- Pathway: 510(k) (Traditional)
- Applicant: Schneider U.S. Stent Div.
- Decided: Nov 29, 1991 after 66 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
57 later devices descend from it; 4 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K961262: Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis (1996), 55 descendants of its own
- K964119: Wallstent Transhepatic Biliary Endoprosthesis (1997), 54 descendants of its own
- K982184: Wallstent Endoprosthesis (1998), 40 descendants of its own
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive (2001), 37 descendants of its own
- K073667: Niti-S Biliary Stent (2008), 23 descendants of its own

Source page: https://510kreport.com/device/K914277
Methodology: https://510kreport.com/methodology