# K101530: Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-D

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Mar 29, 2011 after 299 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: 3 generations back to K000281 (2000). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991056: Wallstent Enteral Endoprosthesis with Unistep Delivery System, Boston Scientific Corp (1999) Summary page 1.
- K062750: Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030, Boston Scientific Corp (2006) Summary page 1.

## Most influential descendants
- 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

## Indications for use
This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Source page: https://510kreport.com/device/K101530
Methodology: https://510kreport.com/methodology