Cleared Special

K031186 - LUMINEXX ENDOSCOPIC BILIARY STENT

K031186 is an FDA 510(k) clearance for LUMINEXX ENDOSCOPIC BILIARY STENT, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 21-day FDA review.

K031186 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
21d
Days
Class 2
Risk

K031186 is an FDA 510(k) clearance for the LUMINEXX ENDOSCOPIC BILIARY STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031186

510(k) Number K031186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 15, 2003
Decision Date May 06, 2003
Days to Decision 21 days
Submission Type Special
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
110d faster than avg
Panel avg: 131d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 477
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K031186.
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
K023666 · Rusch Intl. · Jun 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031197 · Cordis Corp. · Jun 2003
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
K030839 · Medtronic Ave, Inc. · May 2003
PANCREATIC DRAINAGE TUBE
K021672 · Aomori Olympus Co., Ltd. · Apr 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
K023308 · Orbus Medical Technologies · Apr 2003
JOSTENT SELFX, MODELS 015SX4406
K030053 · Jomed AG · Mar 2003
K031186 · LUMINEXX ENDOSCOPIC BILIARY STENT
Download PDF FDA Summary C.R. Bard, Inc.