# K061877: Wallflex Enteral Colonic Stent with Anchor Lock Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 15, 2006 after 74 days
- Product code: MQR (Stent, Colonic, Metallic, Expandable)
- 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: 2 generations back to K000281 (2000). 4 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042065: Wallflex Enternal Colonic Stent and Anchor Lock Delivery System, Boston Scientific Corp (2004) Summary page 1.
- K060323: Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380, Boston Scientific Corporation (2006) Summary page 1.
- K000281: Wallstent Enternal Prosthesis, Boston Scientific Corp (2000) Summary page 1.

## Most influential descendants
- K180180: HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (2018), 4 descendants of its own
- K183616: HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (2019), 3 descendants of its own
- K113510: Evolution Colonic Stent System (2012), 3 descendants of its own
- K190141: HANAROSTENT LowAx Colon/Rectum (NNN) (2019), 2 descendants of its own
- K163468: Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (2017), 2 descendants of its own

## Indications for use
The WallfleXTm Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomny in patients with malignant strictures.

Source page: https://510kreport.com/device/K061877
Methodology: https://510kreport.com/methodology