Cleared Traditional

K012752 - WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE

K012752 is an FDA 510(k) clearance for WALLSTENT RX BILIARY ENDOPROSTHESES, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K012752 · Boston Scientific Corp · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Nov 2001
Decision
91d
Days
Class 2
Risk

K012752 is an FDA 510(k) clearance for the WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on November 15, 2001 after a review of 91 days - within the typical 510(k) review window.

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 Corp devices

FDA 510(k) Submission Details - K012752

510(k) Number K012752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 16, 2001
Decision Date November 15, 2001
Days to Decision 91 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
40d faster than avg
Panel avg: 131d · This submission: 91d
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 394
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K012752.
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · Guidant Corp. · Jan 2002
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · Boston Scientific Corp · Nov 2001
FANELLI BILIARY STENT
K010601 · Cook, Inc. · Nov 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
K012822 · Boston Scientific Scimed, Inc. · Oct 2001
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K012993 · Cordis Corp. · Oct 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K012590 · Cordis Corp. · Sep 2001