Cleared Traditional

K152853 - WALLSTENT RP Endoprosthesis Transhepati...

K152853 is the FDA 510(k) clearance for WALLSTENT RP Endoprosthesis Transhepati... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K152853 · Boston Scientific Corp · Gastroenterology & Urology device
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Nov 2015
Decision
52d
Days
Class 2
Risk

K152853 is an FDA 510(k) clearance for the WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Tr.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on November 20, 2015 after a review of 52 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 Corp devices

Submission Details

510(k) Number K152853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date November 20, 2015
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 305
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K152853.
Zilver 635 Biliary Stent
K163018 · Cook Ireland, Ltd. · Dec 2016
Express SD Biliary Monorail Premounted Stent System
K162404 · Boston Scientific Corporation · Oct 2016
Soehendra Stent Retriever
K161203 · Wilson-Cook Medical, Inc. · May 2016
Elation Wireguided Balloon Dilation Catheter
K151925 · Merit Medical Systems, Inc. · Nov 2015
Express SD Biliary Monorail Premounted Stent System
K152607 · Boston Scientific · Oct 2015
Disposable Multistage Dilation Balloon Catheter
K151671 · Micro-Tech (Nanjing) Co., Ltd. · Oct 2015