Cleared Traditional

K003929 - NIROYAL BILIARY PREMOUNTED STENT SYSTEM

K003929 is an FDA 510(k) clearance for NIROYAL BILIARY PREMOUNTED STENT SYSTEM, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K003929 · Boston Scientific Corp · Gastroenterology & Urology device
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Mar 2001
Decision
92d
Days
Class 2
Risk

K003929 is an FDA 510(k) clearance for the NIROYAL BILIARY PREMOUNTED STENT SYSTEM. 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 March 22, 2001 after a review of 92 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

FDA 510(k) Submission Details - K003929

510(k) Number K003929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 20, 2000
Decision Date March 22, 2001
Days to Decision 92 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
39d faster than avg
Panel avg: 131d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 394
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K003929.
OMNILINK .035 BILIARY STENT SYSTEM
K011506 · Guidant Corp. · Jun 2001
OMNILINK .018 BILIARY STENT SYSTEM
K011039 · Guidant Corp. · May 2001
RX HERCULINK PLUS BILIARY STENT SYSTEM
K010684 · Guidant Corp. · Apr 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
K010445 · Cordis Corp. · Mar 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
K003186 · C.R. Bard, Inc. · Jan 2001
BARD LUMINEXX BILIARY STENT
K003793 · C.R. Bard, Inc. · Jan 2001