Cleared Traditional

K152607 - Express SD Biliary Monorail Premounted ...

K152607 is the FDA 510(k) clearance for Express SD Biliary Monorail Premounted ... by Boston Scientific. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K152607 · Boston Scientific · Gastroenterology & Urology device
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Oct 2015
Decision
46d
Days
Class 2
Risk

K152607 is an FDA 510(k) clearance for the Express SD Biliary Monorail Premounted Stent System. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on October 27, 2015 after a review of 46 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 devices

Submission Details

510(k) Number K152607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2015
Decision Date October 27, 2015
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
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 253
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K152607.
Soehendra Stent Retriever
K161203 · Wilson-Cook Medical, Inc. · May 2016
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
K152853 · Boston Scientific Corp · Nov 2015
Elation Wireguided Balloon Dilation Catheter
K151925 · Merit Medical Systems, Inc. · Nov 2015
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
K152524 · Cook Incorporated · Sep 2015
Single Use Biliary Balloon Dilator
K143303 · Olympus Medical Systems Corp. · Feb 2015
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
K141408 · Merit Medical Systems, Inc. · Nov 2014