Cleared Special

K991032 - GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58

K991032 is an FDA 510(k) clearance for GUIDANT MEGALINK BILIARY STENT, manufactured by Guidant Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 32-day FDA review.

K991032 · Guidant Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
32d
Days
Class 2
Risk

K991032 is an FDA 510(k) clearance for the GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58. 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 April 30, 1999 after a review of 32 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 - K991032

510(k) Number K991032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 29, 1999
Decision Date April 30, 1999
Days to Decision 32 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
99d faster than avg
Panel avg: 131d · This submission: 32d
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 K991032.
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
K991793 · AngioDynamics, Inc. · Jun 1999
CYSTIC DUCT BALLOON DILATING CATHETER
K983154 · Applied Medical Resources · May 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
K990631 · Cordis Corp. · Apr 1999
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
K983075 · Guidant Corp. · Mar 1999
WILSON-COOK PANCREATIC WEDGE STENT
K990130 · Wilson-Cook Medical, Inc. · Feb 1999
ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
K982346 · AngioDynamics, Inc. · Jan 1999
K991032 · GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
Download PDF FDA Summary Guidant Corp.