# K042065: Wallflex Enternal Colonic Stent and Anchor Lock Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 30, 2004 after 59 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 K000281 (2000). 2 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030769: Ultraflex Precision Colonic Stent, Boston Scientific Corp (2003) Summary page 1.
- K000281: Wallstent Enternal Prosthesis, Boston Scientific Corp (2000) Summary page 1.

## Most influential descendants
- K073266: Wallflex Partially Covered Esophageal Stent System (2008), 15 descendants of its own
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 (2009), 14 descendants of its own
- K062750: Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030 (2006), 11 descendants of its own
- K061877: Wallflex Enteral Colonic Stent with Anchor Lock Delivery System (2006), 10 descendants of its own
- K180180: HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (2018), 4 descendants of its own

## Recalls of this device
- Mar 7, 2018 · Class II · Z-3038-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

## Indications for use
The WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.

Source page: https://510kreport.com/device/K042065
Methodology: https://510kreport.com/methodology