Cleared Special

MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON (K013737) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013737 · Telemed Systems, Inc. · Gastroenterology & Urology device
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Mar 2002
Decision
108d
Days
Class 2
Risk

K013737 is an FDA 510(k) clearance for the MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on March 1, 2002 after a review of 108 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Telemed Systems, Inc. devices

Submission Details

510(k) Number K013737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date March 01, 2002
Days to Decision 108 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 130d · This submission: 108d
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 195
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K013737.
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K021345 · Cordis Corp. · Jun 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K020809 · Cordis Corp. · Apr 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682 · C.R. Bard, Inc. · Apr 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052 · Cordis Corp. · Feb 2002
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · Boston Scientific Corp · Nov 2001
FANELLI BILIARY STENT
K010601 · Cook, Inc. · Nov 2001