Cleared Special

SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (K070939) - FDA 510(k) Clearance

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

K070939 · Coloplast Manufacturing Us, LLC · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2007
Decision
58d
Days
Class 2
Risk

K070939 is an FDA 510(k) clearance for the SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Coloplast Manufacturing Us, LLC (Minneapolis, US). The FDA issued a Cleared decision on June 1, 2007 after a review of 58 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 Coloplast Manufacturing Us, LLC devices

Submission Details

510(k) Number K070939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2007
Decision Date June 01, 2007
Days to Decision 58 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 130d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
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 - FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

All 59
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K070939.
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