Cleared Abbreviated

K093392 - MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS

K093392 is an FDA 510(k) clearance for MULTIPURPOSE, manufactured by Navilyst Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Abbreviated 510(k) pathway after a 62-day FDA review.

K093392 · Navilyst Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
62d
Days
Class 2
Risk

K093392 is an FDA 510(k) clearance for the MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS. 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 December 31, 2009 after a review of 62 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K093392

510(k) Number K093392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2009
Decision Date December 31, 2009
Days to Decision 62 days
Submission Type Abbreviated
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
69d faster than avg
Panel avg: 131d · This submission: 62d
Pathway characteristics
Standards-based clearance path.

FGE Device Classification - Class 2, Special Controls

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 477
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K093392.
BONASTENT BILIARY
K093003 · Endochoice, Inc. · Mar 2010
SCUBA BILIARY STENT SYSTEM
K092352 · Invatec S.P.A. · Mar 2010
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
K093947 · Merit Medical Systems, Inc. · Jan 2010
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
K081996 · Flexible Stenting Solutions, Inc. · Sep 2009
BULLSEYE BILIARY STENT SYSTEM
K082093 · Squareone · Jul 2009
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
K083374 · Boston Scientific Corp · Apr 2009
K093392 · MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
Download PDF FDA Summary Navilyst Medical, Inc.