Cleared Special

K101297 - 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.

K101297 · Coloplast A/S · Gastroenterology & Urology device
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Jun 2010
Decision
24d
Days
Class 2
Risk

K101297 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 (Plymouth, US). The FDA issued a Cleared decision on June 3, 2010 after a review of 24 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 K101297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2010
Decision Date June 03, 2010
Days to Decision 24 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
106d faster than avg
Panel avg: 130d · This submission: 24d
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.