Cleared Special

K091152 - VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 (FDA 510(k) Clearance)

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

K091152 · Coloplast A/S · Gastroenterology & Urology device
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May 2009
Decision
17d
Days
Class 2
Risk

K091152 is an FDA 510(k) clearance for the VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020. Classified as Mesh, Surgical, For Stress Urinary Incontinence, Male (product code OTM), Class II - Special Controls.

Submitted by Coloplast A/S (Humlebaek, DK). The FDA issued a Cleared decision on May 7, 2009 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - 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 A/S devices

Submission Details

510(k) Number K091152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2009
Decision Date May 07, 2009
Days to Decision 17 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
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Male Stress Urinary Incontinence Post-prostatectomy
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.