Cleared Special

K012090 - CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012090 · Cordis, A Johnson & Johnson Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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

Submission Details

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.

Device Classification

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 473
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K012090.
Dilation Balloon Catheter
K253832 · Mirco-Tech (Nanjing) Co., Ltd. · Apr 2026
Endoflux™ Biliary & Pancreatic Stent Sets
K251658 · Medi-Globe GmbH · Apr 2026
BARE Wireguided Balloon Dilation Catheter (1235)
K253987 · GIE Medical · Mar 2026
Single use stone retrieval balloons
K253132 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2026
Niti-S Biliary Stent
K251123 · Taewoong Medical Co., Ltd. · Dec 2025
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
K251019 · Bioteque Corporation · Dec 2025