# K062750: Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 4, 2006 after 81 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: 2 generations back to K000281 (2000). 3 ancestors in all.
11 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.
- 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
- 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
- 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

## Indications for use
The WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.

Source page: https://510kreport.com/device/K062750
Methodology: https://510kreport.com/methodology