Cleared Traditional

Rusch Intermittent Urethral Catheters (K173596) - FDA 510(k) Clearance

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

K173596 · Teleflex Medical · Gastroenterology & Urology device
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Jan 2018
Decision
69d
Days
Class 2
Risk

K173596 is an FDA 510(k) clearance for the Rusch Intermittent Urethral Catheters. Classified as Catheter, Coude (product code EZC), Class II - Special Controls.

Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on January 29, 2018 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teleflex Medical devices

Submission Details

510(k) Number K173596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2017
Decision Date January 29, 2018
Days to Decision 69 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
61d faster than avg
Panel avg: 130d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZC Catheter, Coude
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 - EZC Catheter, Coude

Devices cleared under the same product code (EZC) and FDA review panel - the closest regulatory comparables to K173596.
Rusch Intermittent Urethral Catheters
K222279 · Teleflex Medical · Aug 2022
BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER
K913341 · C.R. Bard, Inc. · Jan 1992
BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF
K910846 · C.R. Bard, Inc. · Aug 1991
BARD HYDROGEL-COATED FOLEY CATHETERS
K910195 · C.R. Bard, Inc. · Aug 1991
HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
K910197 · C.R. Bard, Inc. · Aug 1991