# K991056: Wallstent Enteral Endoprosthesis with Unistep Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jun 22, 1999 after 84 days
- Product code: MQR (Stent, Colonic, Metallic, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3610
- 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: 1 generation back to K954290 (1996). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954290: Wallstent Enteral Endoprothesis, Boston Scientific Scimed, Inc. (1996) Summary page 1.
- K980113: Wallstent Enteral Endoprosthesis, Boston Scientific Scimed, Inc. (1998) Summary page 1.

## Most influential descendants
- K101530: Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-D (2011), 4 descendants of its own
- K113510: Evolution Colonic Stent System (2012), 3 descendants of its own
- K163468: Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (2017), 2 descendants of its own
- K200257: WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System (2020), 1 descendant of its own
- K234046: WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System (2024), 0 descendants of its own

## Recalls of this device
- Jun 26, 2003 · Not classified · Z-1019-03: Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm

## Indications for use
The WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is indicated for palliative treatment of colonic, duodenal or gastric outlet obstruction or strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Source page: https://510kreport.com/device/K991056
Methodology: https://510kreport.com/methodology