Cleared Traditional

K982005 - WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS

K982005 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 86-day FDA review.

K982005 · Boston Scientific Scimed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
86d
Days
Class 2
Risk

K982005 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 September 2, 1998 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Scimed, Inc. devices

FDA 510(k) Submission Details - K982005

510(k) Number K982005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date September 02, 1998
Days to Decision 86 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
45d faster than avg
Panel avg: 131d · This submission: 86d
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 K982005.
PERIPHERAL AVE STENT SYSTEM
K983008 · Peripheral Ave · Nov 1998
NIR BILIARY STENT
K973171 · Medinol, Ltd. · Nov 1998
FLEXIMA
K982508 · Boston Scientific Corp · Oct 1998
ITI STENT
K980290 · Intratherapeutics, Inc. · Jul 1998
PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
K980653 · Cordis Corp. · Jun 1998
MANAN VS ACCESS NEEDLE/SET
K980372 · Medical Device Technologies, Inc. · Apr 1998