Cleared Special

K103353 - MULTIPURPOSE DRAINAGE CATHETER

Also marketed or referenced as:
NEPHROSTOMY DRAINAGE CATHETER BILIARY DRAINAGE CATHETER

K103353 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 59-day FDA review.

K103353 · Navilyst Medical, Inc. · Gastroenterology & Urology device
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Jan 2011
Decision
59d
Days
Class 2
Risk

K103353 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 January 14, 2011 after a review of 59 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 K103353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2010
Decision Date January 14, 2011
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
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 K103353.
MULTIPURPOSE DRAINAGE CATHETER
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K102082 · Boston Scientific Corp · Aug 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
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ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · Boston Scientific Corp · Jul 2010