Cleared Special

K033212 - LIFESTENT SDS BILIARY ENDOPROSTHESIS

K033212 is an FDA 510(k) clearance for LIFESTENT SDS BILIARY ENDOPROSTHESIS, 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 27-day FDA review.

K033212 · Orbus Medical Technologies · Gastroenterology & Urology device
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Oct 2003
Decision
27d
Days
Class 2
Risk

K033212 is an FDA 510(k) clearance for the LIFESTENT 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 October 30, 2003 after a review of 27 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 - K033212

510(k) Number K033212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 03, 2003
Decision Date October 30, 2003
Days to Decision 27 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
103d faster than avg
Panel avg: 130d · This submission: 27d
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 K033212.
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K033314 · Ev3, Inc. · Nov 2003
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134 · Ev3, Inc. · Nov 2003
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393 · Guidant Corp. · Nov 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K032580 · Ev3, Inc. · Oct 2003
SENTINOL NITINOL BILLARY STENT SYSTEM
K032025 · Boston Scientific Corp · Sep 2003
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032137 · Cordis Corp. · Sep 2003