# K163468: Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: May 4, 2017 after 143 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
Longest line of descent: 5 generations back to K000281 (2000). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101530: Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-D, Cook Ireland, Ltd. (2011) Summary page 5.
- K113510: Evolution Colonic Stent System, Cook Ireland, Ltd. (2012) Summary page 5.

## Most influential descendants
- 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

## Indications for use
Evolution® Duodenal Stent System- Uncovered: This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms. Evolution® Colonic Stent System- Uncovered: This device is used for palliative treatment of colonic obstruction or colonic 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/K163468
Methodology: https://510kreport.com/methodology