Cleared Special

K014184 - MODIFICATION TO DYNALINK .035 BILIARY S...

K014184 is the FDA 510(k) clearance for MODIFICATION TO DYNALINK .035 BILIARY S... by Guidant Corp.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 29-day FDA review.

K014184 · Guidant Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
29d
Days
Class 2
Risk

K014184 is an FDA 510(k) clearance for the MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Guidant Corp. (Santa Clara, US). The FDA issued a Cleared decision on January 18, 2002 after a review of 29 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 Guidant Corp. devices

Submission Details

510(k) Number K014184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 20, 2001
Decision Date January 18, 2002
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
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 305
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K014184.
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K020809 · Cordis Corp. · Apr 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682 · C.R. Bard, Inc. · Apr 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052 · Cordis Corp. · Feb 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · Guidant Corp. · Jan 2002
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · Boston Scientific Corp · Nov 2001
FANELLI BILIARY STENT
K010601 · Cook, Inc. · Nov 2001