Cleared Traditional

BONASTENT BILIARY (K140760) - FDA 510(k) Clearance

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

K140760 · Endochoice, Inc. · Gastroenterology & Urology device
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Jun 2014
Decision
82d
Days
Class 2
Risk

K140760 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. (Toronto, CA). The FDA issued a Cleared decision on June 16, 2014 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Endochoice, Inc. devices

Submission Details

510(k) Number K140760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 26, 2014
Decision Date June 16, 2014
Days to Decision 82 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
48d faster than avg
Panel avg: 130d · This submission: 82d
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 K140760.
EXPEL APD DRAINAGE CATHETER SYSTEM
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MUSTANG BALLOON DIALATION CATHETER
K141597 · Boston Scientific Corporation · Aug 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
K133110 · Boston Scientific Corporation · Jul 2014
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
K133700 · Boston Scientific Corporation · May 2014
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
K130981 · Cordis Corp. · Mar 2014
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
K131201 · Cook, Inc. · Oct 2013