Cleared Special

K051379 - PROTEGE RX GPS SELF-EXPANDING NITRINOL ...

K051379 is an FDA 510(k) clearance for PROTEGE RX GPS SELF-EXPANDING NITRINOL ..., manufactured by Ev3 Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 21-day FDA review.

K051379 · Ev3 Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
21d
Days
Class 2
Risk

K051379 is an FDA 510(k) clearance for the PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Ev3 Corporation (Plymouth, US). The FDA issued a Cleared decision on June 17, 2005 after a review of 21 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 Ev3 Corporation devices

FDA 510(k) Submission Details - K051379

510(k) Number K051379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 27, 2005
Decision Date June 17, 2005
Days to Decision 21 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 130d · This submission: 21d
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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K051379.
FORMULA 418 BILIARY STENT
K051785 · Cook, Inc. · Aug 2005
ZILVER 635 BILIARY STENT
K051124 · Cook, Inc. · Jul 2005
SINGLE USE BALLOON DILATOR MAXPASSTM
K050502 · Olympus Winter & Ibe GmbH · Jul 2005
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050534 · Abbott Laboratories · May 2005
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
K050777 · Conmedcorp · Apr 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
K050698 · Cook, Inc. · Mar 2005