Cleared Traditional

BONASTENT BILIARY (K093003) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093003 · Endochoice, Inc. · Gastroenterology & Urology device
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Mar 2010
Decision
177d
Days
Class 2
Risk

K093003 is an FDA 510(k) clearance for the BONASTENT BILIARY. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Endochoice, Inc. (Chalotte, US). The FDA issued a Cleared decision on March 24, 2010 after a review of 177 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 Endochoice, Inc. devices

Submission Details

510(k) Number K093003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 28, 2009
Decision Date March 24, 2010
Days to Decision 177 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 130d · This submission: 177d
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 224
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K093003.
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
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ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · Boston Scientific Corp · Jul 2010
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
K101095 · Wilson-Cook Medical, Inc. · Jul 2010
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
K093947 · Merit Medical Systems, Inc. · Jan 2010
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
K083374 · Boston Scientific Corp · Apr 2009
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
K083627 · Boston Scientific Corporation · Apr 2009