Cleared Traditional

K964119 - WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS

K964119 is an FDA 510(k) clearance for WALLSTENT TRANSHEPATIC BILIARY ENDOPROS..., manufactured by Boston Scientific Scimed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K964119 · Boston Scientific Scimed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
195d
Days
Class 2
Risk

K964119 is an FDA 510(k) clearance for the WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 28, 1997 after a review of 195 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 Boston Scientific Scimed, Inc. devices

FDA 510(k) Submission Details - K964119

510(k) Number K964119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date April 28, 1997
Days to Decision 195 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 131d · This submission: 195d
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 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K964119.
ULTRAFLEX DIAMOND
K962899 · Boston Scientific Corp · May 1997
MANAN V.S. ACCESS NEEDLE/SET
K963767 · Manan Medical Products, Inc. · May 1997
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
K963782 · C.R. Bard, Inc. · May 1997
EXTRACTORRX
K970052 · Boston Scientific Corp · Mar 1997
COURIER BALLOON DILATATION CATHETER
K963691 · Boston Scientific Corp · Dec 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K963397 · Boston Scientific Corp · Nov 1996