Cleared Traditional

K081996 - FLEXSTENT BILIARY SELF EXPANDING STENT ...

K081996 is an FDA 510(k) clearance for FLEXSTENT BILIARY SELF EXPANDING STENT ..., manufactured by Flexible Stenting Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K081996 · Flexible Stenting Solutions, Inc. · Gastroenterology & Urology device
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Sep 2009
Decision
428d
Days
Class 2
Risk

K081996 is an FDA 510(k) clearance for the FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Flexible Stenting Solutions, Inc. (Eatontown, US). The FDA issued a Cleared decision on September 15, 2009 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Flexible Stenting Solutions, Inc. devices

FDA 510(k) Submission Details - K081996

510(k) Number K081996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 14, 2008
Decision Date September 15, 2009
Days to Decision 428 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
298d slower than avg
Panel avg: 130d · This submission: 428d
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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K081996.
BONASTENT BILIARY
K093003 · Endochoice, Inc. · Mar 2010
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
K093947 · Merit Medical Systems, Inc. · Jan 2010
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
K093392 · Navilyst Medical, Inc. · Dec 2009
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
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
K090133 · Cook, Inc. · Feb 2009