Cleared Traditional

GentleCath Glide Intermittent Catheter (K161344) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161344 · Convatec Limited · Gastroenterology & Urology device
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Sep 2016
Decision
130d
Days
Class 2
Risk

K161344 is an FDA 510(k) clearance for the GentleCath Glide Intermittent Catheter. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Convatec Limited (Deeside, GB). The FDA issued a Cleared decision on September 20, 2016 after a review of 130 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 Limited devices

Submission Details

510(k) Number K161344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2016
Decision Date September 20, 2016
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K161344.
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
K171810 · Cook Incorporated · Mar 2018
Renal Access Cobra Catheter, Kumpe Access Catheter
K171600 · Cook Incorporated · Feb 2018
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter
K171662 · Cook Incorporated · Feb 2018
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · Boston Scientific Corporation · Nov 2010
BARD TIGERTAIL URETERAL CATHETER
K033719 · C.R. Bard, Inc. · Feb 2004
URETERAL ACCESS SHEATH SET (UASS)
K022135 · Boston Scientific Corp · Sep 2002