Cleared Special

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

K234046 · Boston Scientific Corporation · Gastroenterology & Urology

Mar 2024

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K234046 is an FDA 510(k) clearance for the 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, a Stent, Colonic, Metallic, Expandable (Class II — Special Controls, product code MQR), submitted by Boston Scientific Corporation (Malborough, US). The FDA issued a Cleared decision on March 8, 2024, 78 days after receiving the submission on December 21, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number	K234046 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2023
Decision Date	March 08, 2024
Days to Decision	78 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF