Cleared Traditional

WALLSTENT ENTERAL ENDOPROTHESIS (K954290) - FDA 510(k) Clearance

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

K954290 · Boston Scientific Scimed, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
300d
Days
Class 2
Risk

K954290 is an FDA 510(k) clearance for the WALLSTENT ENTERAL ENDOPROTHESIS. Classified as Stent, Colonic, Metallic, Expandable (product code MQR), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 10, 1996 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Scimed, Inc. devices

Submission Details

510(k) Number K954290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1995
Decision Date July 10, 1996
Days to Decision 300 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 130d · This submission: 300d
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 K954290.
WallFlex Colonic Stent System with Anchor Lock Delivery System
K234046 · Boston Scientific Corporation · Mar 2024
WallFlex Colonic Stent System with Anchor Lock Delivery System
K201159 · Boston Scientific Corporation · Aug 2020
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