Cleared Traditional

K103371 - COUDE/ OR TIEMANN

K103371 is the FDA 510(k) clearance for COUDE/ OR TIEMANN by Degania Silicone , Ltd.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K103371 · Degania Silicone , Ltd. · Gastroenterology & Urology device
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Mar 2011
Decision
114d
Days
Class 2
Risk

K103371 is an FDA 510(k) clearance for the COUDE/ OR TIEMANN. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Degania Silicone , Ltd. (Emek Hayarden, IL). The FDA issued a Cleared decision on March 11, 2011 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Degania Silicone , Ltd. devices

Submission Details

510(k) Number K103371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2010
Decision Date March 11, 2011
Days to Decision 114 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 130d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EZL Catheter, Retention Type, Balloon

All 59
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K103371.
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3 WAY SILICONE FOLEY BALLOON CATHETER
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BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
K070558 · C.R. Bard, Inc. · Dec 2007
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
K070582 · C.R. Bard, Inc. · Dec 2007