Cleared Traditional

K023666 - RUSCH GUIDED CHOLANGIOGRAPHY CATHETER

K023666 is the FDA 510(k) clearance for RUSCH GUIDED CHOLANGIOGRAPHY CATHETER by Rusch Intl.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K023666 · Rusch Intl. · Gastroenterology & Urology device
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Jun 2003
Decision
229d
Days
Class 2
Risk

K023666 is an FDA 510(k) clearance for the RUSCH GUIDED CHOLANGIOGRAPHY CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on June 17, 2003 after a review of 229 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rusch Intl. devices

Submission Details

510(k) Number K023666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2002
Decision Date June 17, 2003
Days to Decision 229 days
Submission Type Traditional
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
99d slower than avg
Panel avg: 130d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 299
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K023666.
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MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031777 · Cordis Corp. · Jul 2003
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
K024303 · Edwards Lifesciences, LLC · Jul 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031197 · Cordis Corp. · Jun 2003
LUMINEXX ENDOSCOPIC BILIARY STENT
K031186 · C.R. Bard, Inc. · May 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
K030645 · Boston Scientific Corp · Mar 2003