Cleared Traditional

K103478 - SINGLE USE BILIARY DRAINAGE STENT V

K103478 is the FDA 510(k) clearance for SINGLE USE BILIARY DRAINAGE STENT V by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K103478 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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Feb 2011
Decision
90d
Days
Class 2
Risk

K103478 is an FDA 510(k) clearance for the SINGLE USE BILIARY DRAINAGE STENT V. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on February 24, 2011 after a review of 90 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K103478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2010
Decision Date February 24, 2011
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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 257
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K103478.
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
K112543 · Boston Scientific Corporation · Dec 2011
CHARGER BALLOON DILATATION CATHETER
K112701 · Boston Scientific · Oct 2011
MUSTANG BALLOON DILATAION CATHETERS
K110122 · Boston Scientific · May 2011
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
K102082 · Boston Scientific Corp · Aug 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
K101314 · Boston Scientific Corp · Jul 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · Boston Scientific Corp · Jul 2010