Name: Predicase
Price: 199 USD

K-number	K234046
Device name	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
Applicant	Boston Scientific Corporation
Product code	MQR
Device class	Class II
Decision date	Mar 8, 2024
Decision	Substantially Equivalent
Regulation	878.3610

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Source

View the full FDA submission: accessdata.fda.gov

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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

Everything you need for a 510(k) submission. Nothing you don't.