Cleared Special

K040653 - PARAMOUNT MINI GPS BILIARY STENT SYSTEM

K040653 is an FDA 510(k) clearance for PARAMOUNT MINI GPS BILIARY STENT SYSTEM, manufactured by Ev3, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 47-day FDA review.

K040653 · Ev3, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
47d
Days
Class 2
Risk

K040653 is an FDA 510(k) clearance for the PARAMOUNT MINI GPS BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Ev3, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 28, 2004 after a review of 47 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 - K040653

510(k) Number K040653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 12, 2004
Decision Date April 28, 2004
Days to Decision 47 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
84d faster than avg
Panel avg: 131d · This submission: 47d
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 K040653.
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
K041370 · Orbus Medical Technologies · Jun 2004
CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K040413 · Cordis Europa, N.V. · Jun 2004
MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
K041032 · Orbus Medical Technologies · May 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
K040667 · Abbott Laboratories · Apr 2004
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
K040027 · Boston Scientific · Mar 2004
ZILVER 635 BILIARY STENT
K040505 · Cook, Inc. · Mar 2004
K040653 · PARAMOUNT MINI GPS BILIARY STENT SYSTEM
Download PDF FDA Summary Ev3, Inc.