Cleared Special

K222279 - Rusch Intermittent Urethral Catheters (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222279 · Teleflex Medical · Gastroenterology & Urology device
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Aug 2022
Decision
31d
Days
Class 2
Risk

K222279 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 August 29, 2022 after a review of 31 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Teleflex Medical devices

Submission Details

510(k) Number K222279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2022
Decision Date August 29, 2022
Days to Decision 31 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 130d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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.