Cleared Special

K073672 - SKATER BILIARY CATHETER

K073672 is an FDA 510(k) clearance for SKATER BILIARY CATHETER, manufactured by Angiotech. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 28-day FDA review.

K073672 · Angiotech · Gastroenterology & Urology device
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Jan 2008
Decision
28d
Days
Class 2
Risk

K073672 is an FDA 510(k) clearance for the SKATER BILIARY CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Angiotech (Herndon, US). The FDA issued a Cleared decision on January 24, 2008 after a review of 28 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 Angiotech devices

FDA 510(k) Submission Details - K073672

510(k) Number K073672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2007
Decision Date January 24, 2008
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 131d · This submission: 28d
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 412
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K073672.
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
K072301 · Ev3, Inc. · Mar 2008
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
K062798 · Cordis Corp. · Feb 2008
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
K071646 · Idev Technologies, Inc. · Jan 2008
RESOLVE BILIARY DRAINAGE CATHETER
K063733 · Merit Medical Systems, Inc. · Nov 2007
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
K062264 · Medtronic Vascular · Nov 2007
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
K063481 · Abbott Vascular, Inc. · Sep 2007