Cleared Traditional

K023308 - LIFESTENT SDS BILIARY ENDOPROSTHESIS

K023308 is an FDA 510(k) clearance for LIFESTENT SDS BILIARY ENDOPROSTHESIS, manufactured by Orbus Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K023308 · Orbus Medical Technologies · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2003
Decision
193d
Days
Class 2
Risk

K023308 is an FDA 510(k) clearance for the LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Orbus Medical Technologies (Fort Lauderdale, US). The FDA issued a Cleared decision on April 14, 2003 after a review of 193 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 Orbus Medical Technologies devices

FDA 510(k) Submission Details - K023308

510(k) Number K023308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 03, 2002
Decision Date April 14, 2003
Days to Decision 193 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
63d slower than avg
Panel avg: 130d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K023308.
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
K023666 · Rusch Intl. · Jun 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031197 · Cordis Corp. · Jun 2003
LUMINEXX ENDOSCOPIC BILIARY STENT
K031186 · C.R. Bard, Inc. · May 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
K030645 · Boston Scientific Corp · Mar 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107 · Boston Scientific Corp · Mar 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
K030409 · Cordis Corp. · Mar 2003