Cleared Traditional

K961262 - WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS

K961262 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 38-day FDA review.

K961262 · Boston Scientific Scimed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
38d
Days
Class 2
Risk

K961262 is an FDA 510(k) clearance for the WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY EN.... 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 May 10, 1996 after a review of 38 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 - K961262

510(k) Number K961262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1996
Decision Date May 10, 1996
Days to Decision 38 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
93d faster than avg
Panel avg: 131d · This submission: 38d
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 K961262.
DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
K954713 · Ideas For Medicine, Inc. · Jul 1996
MANAN INTRODUCER SHEALTH/NEEDLE
K961216 · Manan Medical Products, Inc. · May 1996
LMI BILIARY CATHETER
K955126 · Lucas Medical, Inc. · May 1996
CORDIS BILIARY STENT
K955728 · Cordis Corp. · May 1996
MANAN BILIARY DRAINAGE CATHETER
K954043 · Manan Medical Products, Inc. · Mar 1996
ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER
K955413 · Endovations · Feb 1996