Cleared Traditional

K001338 - MICROVASIVE RAPID EXCHANGE BILIARY BALL...

K001338 is the FDA 510(k) clearance for MICROVASIVE RAPID EXCHANGE BILIARY BALL... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K001338 · Boston Scientific Corp · Gastroenterology & Urology device
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Aug 2000
Decision
125d
Days
Class 2
Risk

K001338 is an FDA 510(k) clearance for the MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on August 30, 2000 after a review of 125 days - within the typical 510(k) review window.

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 Boston Scientific Corp devices

Submission Details

510(k) Number K001338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2000
Decision Date August 30, 2000
Days to Decision 125 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
5d faster than avg
Panel avg: 130d · This submission: 125d
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 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K001338.
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365 · Cordis Corp. · Nov 2000
NIR BILLIARY STENT SYSTEM
K002133 · Boston Scientific Corp · Oct 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
K002143 · Guidant Corp. · Oct 2000
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
K002101 · AngioDynamics, Inc. · Jul 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K001843 · Cordis Corp. · Jul 2000
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
K001258 · Cordis Corp. · Jun 2000