Cleared Special

K041032 - MODIFICATION TO LIFESTENT SDS AND XL SD...

K041032 is an FDA 510(k) clearance for MODIFICATION TO LIFESTENT SDS AND XL SD..., manufactured by Orbus Medical Technologies. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 19-day FDA review.

K041032 · Orbus Medical Technologies · Gastroenterology & Urology device
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May 2004
Decision
19d
Days
Class 2
Risk

K041032 is an FDA 510(k) clearance for the MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Orbus Medical Technologies (Fort Lauderdale, US). The FDA issued a Cleared decision on May 10, 2004 after a review of 19 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 Orbus Medical Technologies devices

FDA 510(k) Submission Details - K041032

510(k) Number K041032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 21, 2004
Decision Date May 10, 2004
Days to Decision 19 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
111d faster than avg
Panel avg: 130d · This submission: 19d
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 K041032.
EXTRACTOR RX RETRIEVAL BALLOON
K041606 · Boston Scientific Corp · Jul 2004
ZILVER BILIARY STENT SYSTEM USW
K040930 · Wilson-Cook Medical, Inc. · Jul 2004
WILOSN-COOK BILIARY DILATION BALLOON
K040800 · Wilson-Cook Medical, Inc. · Jun 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
K040653 · Ev3, Inc. · Apr 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