Name: Predicase
Price: 199 USD

K-number	K201159
Device name	WallFlex Colonic Stent System with Anchor Lock Delivery System
Applicant	Boston Scientific Corporation
Product code	MQR
Device class	Class II
Decision date	Aug 17, 2020
Decision	Substantially Equivalent
Regulation	878.3610

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

WallFlex Colonic Stent System with Anchor Lock Delivery System

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