Cleared Traditional

INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS (K945498) - FDA 510(k) Clearance

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

K945498 · Instent, Inc. · Gastroenterology & Urology device
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Sep 1995
Decision
308d
Days
Class 2
Risk

K945498 is an FDA 510(k) clearance for the INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Instent, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 308 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Instent, Inc. devices

Submission Details

510(k) Number K945498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date September 12, 1995
Days to Decision 308 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
178d slower than avg
Panel avg: 130d · This submission: 308d
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 181
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K945498.
COURIER BALLOON DILATATION CATHETER
K963691 · Boston Scientific Corp · Dec 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K963397 · Boston Scientific Corp · Nov 1996
CORDIS BILIARY STENT
K955728 · Cordis Corp. · May 1996
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · Boston Scientific Corp · Sep 1994
ELIMINATOR BALLOON DILATOR
K940965 · C.R. Bard, Inc. · May 1994
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · Boston Scientific Corp · Jan 1994