Cleared Traditional

K141335 - EXPEL APD DRAINAGE CATHETER SYSTEM

K141335 is the FDA 510(k) clearance for EXPEL APD DRAINAGE CATHETER SYSTEM by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K141335 · Boston Scientific Corp · Gastroenterology & Urology device
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Oct 2014
Decision
149d
Days
Class 2
Risk

K141335 is an FDA 510(k) clearance for the EXPEL APD DRAINAGE CATHETER SYSTEM. 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 October 17, 2014 after a review of 149 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

Submission Details

510(k) Number K141335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date October 17, 2014
Days to Decision 149 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
19d slower than avg
Panel avg: 130d · This submission: 149d
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 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K141335.
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
K152069 · Navilyst Medical, Inc. · 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
MUSTANG BALLOON DIALATION CATHETER
K141597 · Boston Scientific Corporation · Aug 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
K133110 · Boston Scientific Corporation · Jul 2014
WALLFLEX BILIARY RX STENT SYSTEM
K140630 · Boston Scientific · May 2014