Cleared Traditional

K111627 - SUPERA VERITAS INTERWOVEN SELF-EXPANDIN...

K111627 is an FDA 510(k) clearance for SUPERA VERITAS INTERWOVEN SELF-EXPANDIN..., manufactured by Idev Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 438-day FDA review.

K111627 · Idev Technologies, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2012
Decision
438d
Days
Class 2
Risk

K111627 is an FDA 510(k) clearance for the SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIAR.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Idev Technologies, Inc. (Webster, US). The FDA issued a Cleared decision on August 21, 2012 after a review of 438 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 Idev Technologies, Inc. devices

FDA 510(k) Submission Details - K111627

510(k) Number K111627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 10, 2011
Decision Date August 21, 2012
Days to Decision 438 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
308d slower than avg
Panel avg: 130d · This submission: 438d
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 K111627.
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WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
K122072 · Boston Scientific Corporation · Sep 2012
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
K121832 · Merit Medical Systems, Inc. · Jul 2012
CRE DITATATION BALLON
K112994 · Boston Scientific Corporation · Feb 2012
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
K112543 · Boston Scientific Corporation · Dec 2011