Cleared Traditional

WallFlex Colonic Stent System with Anchor Lock Delivery System (K201159) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201159 · Boston Scientific Corporation · Gastroenterology & Urology device
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Aug 2020
Decision
109d
Days
Class 2
Risk

K201159 is an FDA 510(k) clearance for the WallFlex Colonic Stent System with Anchor Lock Delivery System. Classified as Stent, Colonic, Metallic, Expandable (product code MQR), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on August 17, 2020 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K201159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2020
Decision Date August 17, 2020
Days to Decision 109 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 130d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQR Stent, Colonic, Metallic, Expandable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MQR Stent, Colonic, Metallic, Expandable

All 15
Devices cleared under the same product code (MQR) and FDA review panel - the closest regulatory comparables to K201159.
WallFlex Colonic Stent System with Anchor Lock Delivery System
K234046 · Boston Scientific Corporation · Mar 2024
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
K200257 · Boston Scientific Corporation · Apr 2020
HANAROSTENT LowAx Colon/Rectum (NNN)
K190141 · M.I. Tech Co., Ltd. · Mar 2019
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
K183616 · M.I. Tech Co., Ltd. · Jan 2019
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
K180180 · M.I. Tech Co., Ltd. · Nov 2018
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K061877 · Boston Scientific Corp · Sep 2006