Cleared Special

K111315 - MULTIPURPOSE DRAINAGE CATHETER

K111315 is the FDA 510(k) clearance for MULTIPURPOSE DRAINAGE CATHETER by Navilyst Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 29-day FDA review.

K111315 · Navilyst Medical, Inc. · Gastroenterology & Urology device
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Jun 2011
Decision
29d
Days
Class 2
Risk

K111315 is an FDA 510(k) clearance for the MULTIPURPOSE DRAINAGE CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on June 8, 2011 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Navilyst Medical, Inc. devices

Submission Details

510(k) Number K111315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2011
Decision Date June 08, 2011
Days to Decision 29 days
Submission Type Special
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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K111315.
CRE DITATATION BALLON
K112994 · Boston Scientific Corporation · Feb 2012
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
K112543 · Boston Scientific Corporation · Dec 2011
CHARGER BALLOON DILATATION CATHETER
K112701 · Boston Scientific · Oct 2011
MUSTANG BALLOON DILATAION CATHETERS
K110122 · Boston Scientific · May 2011
SINGLE USE BILIARY DRAINAGE STENT V
K103478 · Olympus Medical Systems Corporation · Feb 2011
MULTIPURPOSE DRAINAGE CATHETER
K103353 · Navilyst Medical, Inc. · Jan 2011