Cleared Traditional

K060323 - ULTRAFLEX PRECISION COLONIC STENT

K060323 is the FDA 510(k) clearance for ULTRAFLEX PRECISION COLONIC STENT by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code MQR) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K060323 · Boston Scientific Corporation · Gastroenterology & Urology device
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May 2006
Decision
92d
Days
Class 2
Risk

K060323 is an FDA 510(k) clearance for the ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380. 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 May 12, 2006 after a review of 92 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 K060323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2006
Decision Date May 12, 2006
Days to Decision 92 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
38d faster than avg
Panel avg: 130d · This submission: 92d
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 14
Devices cleared under the same product code (MQR) and FDA review panel - the closest regulatory comparables to K060323.
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
K180180 · M.I. Tech Co., Ltd. · Nov 2018
EVOLUTION COLONIC STENT SYSTEM
K113510 · Cook Ireland, Ltd. · May 2012
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K061877 · Boston Scientific Corp · Sep 2006
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
K042065 · Boston Scientific Corp · Sep 2004
ULTRAFLEX PRECISION COLONIC STENT
K030769 · Boston Scientific Corp · Jul 2003
WALLSTENT ENTERNAL PROSTHESIS
K000281 · Boston Scientific Corp · May 2000