Cleared Traditional

K140953 - GENTLECATH MALE COUDE OLIVE TIP INTERMI...

K140953 is an FDA 510(k) clearance for GENTLECATH MALE COUDE OLIVE TIP INTERMI..., manufactured by Convatec, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K140953 · Convatec, Ltd. · Gastroenterology & Urology device
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Aug 2014
Decision
109d
Days
Class 2
Risk

K140953 is an FDA 510(k) clearance for the GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Convatec, Ltd. (Deeside, GB). The FDA issued a Cleared decision on August 1, 2014 after a review of 109 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 Convatec, Ltd. devices

FDA 510(k) Submission Details - K140953

510(k) Number K140953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2014
Decision Date August 01, 2014
Days to Decision 109 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 130d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
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 - KOD Catheter, Urological

All 129
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K140953.
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