Cleared Special

K012090 - CORDIS PALMAZ GENESIS TRANSHEPATIC BILI...

K012090 is an FDA 510(k) clearance for CORDIS PALMAZ GENESIS TRANSHEPATIC BILI..., manufactured by Cordis, A Johnson & Johnson Co.. 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.

K012090 · Cordis, A Johnson & Johnson Co. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2001
Decision
27d
Days
Class 2
Risk

K012090 is an FDA 510(k) clearance for the CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cordis, A Johnson & Johnson Co. (Warren, US). The FDA issued a Cleared decision on August 1, 2001 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 Cordis, A Johnson & Johnson Co. devices

FDA 510(k) Submission Details - K012090

510(k) Number K012090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 05, 2001
Decision Date August 01, 2001
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 K012090.
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216 · Boston Scientific Scimed, Inc. · Aug 2001
COOK ZILVER BILIARY STENT
K010242 · Cook, Inc. · Aug 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · Cordis Corp. · Aug 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881 · Guidant Corp. · Jul 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506 · Guidant Corp. · Jun 2001
OMNILINK .018 BILIARY STENT SYSTEM
K011039 · Guidant Corp. · May 2001