Cleared Traditional

Rusch Silicone Foley Catheter (K161770) - FDA 510(k) Clearance

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

K161770 · Teleflexmedical, Inc. · Gastroenterology & Urology device
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May 2017
Decision
311d
Days
Class 2
Risk

K161770 is an FDA 510(k) clearance for the Rusch Silicone Foley Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on May 5, 2017 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Teleflexmedical, Inc. devices

Submission Details

510(k) Number K161770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2016
Decision Date May 05, 2017
Days to Decision 311 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
181d slower than avg
Panel avg: 130d · This submission: 311d
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 46
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K161770.
Silicone Foley Catheter for single use
K172807 · Changzhou Rongxin Medicine Minimal Invasion Technology · Jun 2018
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
K173533 · Poiesis Medical, LLC · Mar 2018
Kohli Urinary Drainage Catheter
K172422 · Nellie Medical, LLC · Feb 2018
Bard LubriGuard Foley Catheter
K150699 · C.R. Bard, Inc. · Jul 2015
Medline Silicone Foley Catheter
K142635 · Medline Industries, Inc. · Jan 2015
3 WAY SILICONE FOLEY BALLOON CATHETER
K091767 · Cook Urological, Inc. · Oct 2009