Cleared Traditional

K042065 - WALLFLEX ENTERNAL COLONIC STENT AND ANC...

K042065 is the FDA 510(k) clearance for WALLFLEX ENTERNAL COLONIC STENT AND ANC... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code MQR) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K042065 · Boston Scientific Corp · Gastroenterology & Urology device
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Sep 2004
Decision
59d
Days
Class 2
Risk

K042065 is an FDA 510(k) clearance for the WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM. Classified as Stent, Colonic, Metallic, Expandable (product code MQR), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on September 30, 2004 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K042065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date September 30, 2004
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
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 13
Devices cleared under the same product code (MQR) and FDA review panel - the closest regulatory comparables to K042065.
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
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
K060323 · Boston Scientific Corporation · May 2006
ULTRAFLEX PRECISION COLONIC STENT
K030769 · Boston Scientific Corp · Jul 2003
WALLSTENT ENTERNAL PROSTHESIS
K000281 · Boston Scientific Corp · May 2000
MEMOTHERM COLORECTAL STENT
K990504 · C.R. Bard, Inc. · Mar 2000