Cleared Special

XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050534) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050534 · Abbott Laboratories · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
79d
Days
Class 2
Risk

K050534 is an FDA 510(k) clearance for the XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Abbott Laboratories (Redwood, US). The FDA issued a Cleared decision on May 20, 2005 after a review of 79 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.

View all Abbott Laboratories devices

Submission Details

510(k) Number K050534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 02, 2005
Decision Date May 20, 2005
Days to Decision 79 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
51d faster than avg
Panel avg: 130d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 212
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K050534.
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
K052132 · Edwards Lifesciences, LLC · Aug 2005
FORMULA 418 BILIARY STENT
K051785 · Cook, Inc. · Aug 2005
ZILVER 635 BILIARY STENT
K051124 · Cook, Inc. · Jul 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
K050698 · Cook, Inc. · Mar 2005
LIFESTENT TURBO BILIARY STENT SYSTEMS
K050627 · Edwards Lifesciences, LLC · Mar 2005
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050103 · Abbott Laboratories · Feb 2005