Cleared Special

K991793 - ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM

K991793 is an FDA 510(k) clearance for ANGIODYNAMICS BALLOON EXPANDABLE BILIAR..., manufactured by AngioDynamics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 30-day FDA review.

K991793 · AngioDynamics, Inc. · Gastroenterology & Urology device
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Jun 1999
Decision
30d
Days
Class 2
Risk

K991793 is an FDA 510(k) clearance for the ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on June 25, 1999 after a review of 30 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 - K991793

510(k) Number K991793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1999
Decision Date June 25, 1999
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
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: 131d · This submission: 30d
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 K991793.
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
K990854 · Innerdyne, Inc. · Aug 1999
MEDTRONIC AVE BRIDGE STENT
K992318 · Medtronic Ave, Inc. · Aug 1999
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
K991533 · Peripheral Ave · Jul 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 FG1002949-58
K991032 · Guidant Corp. · Apr 1999
K991793 · ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
Download PDF AngioDynamics, Inc.