Cleared Traditional

K092352 - SCUBA BILIARY STENT SYSTEM

K092352 is an FDA 510(k) clearance for SCUBA BILIARY STENT SYSTEM, manufactured by Invatec S.P.A.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K092352 · Invatec S.P.A. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2010
Decision
224d
Days
Class 2
Risk

K092352 is an FDA 510(k) clearance for the SCUBA BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Invatec S.P.A. (Bethlehem, US). The FDA issued a Cleared decision on March 16, 2010 after a review of 224 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 Invatec S.P.A. devices

FDA 510(k) Submission Details - K092352

510(k) Number K092352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 04, 2009
Decision Date March 16, 2010
Days to Decision 224 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
94d slower than avg
Panel avg: 130d · This submission: 224d
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 K092352.
ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · Boston Scientific Corp · Jul 2010
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
K101095 · Wilson-Cook Medical, Inc. · Jul 2010
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