# K980113: Wallstent Enteral Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Apr 3, 1998 after 80 days
- Product code: MUM (Stent, Metallic, Expandable, Duodenal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
47 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) WALLSTENT® Enteral Endoprosthesis: named in the summary without a submission number

## Most influential descendants
- 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
- K030107: 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM (2003), 11 descendants of its own
- K113551: Esophageal TTS Stent (2012), 10 descendants of its own

## Indications for use
The Schneider (USA) Inc Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.

Source page: https://510kreport.com/device/K980113
Methodology: https://510kreport.com/methodology