Cleared Traditional

K965147 - BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

K965147 is an FDA 510(k) clearance for BILIARY STENT, 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 189-day FDA review.

K965147 · Boston Scientific Corp · Gastroenterology & Urology device
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Jun 1997
Decision
189d
Days
Class 2
Risk

K965147 is an FDA 510(k) clearance for the BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS. 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 June 30, 1997 after a review of 189 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 Corp devices

FDA 510(k) Submission Details - K965147

510(k) Number K965147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date June 30, 1997
Days to Decision 189 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
58d slower than avg
Panel avg: 131d · This submission: 189d
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 K965147.
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K972825 · Cordis Corp. · Oct 1997
SILICONE BILIARY STENT/BILIARY CATHETER
K973114 · Specialty Surgical Products, Inc. · Sep 1997
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
K972583 · Uresil Corp. · Aug 1997
LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
K964688 · Cordis Corp. · Jun 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K963254 · Boston Scientific Corp · May 1997
ULTRAFLEX DIAMOND
K962899 · Boston Scientific Corp · May 1997