Cleared Traditional

K113496 - VIRTURE MALE SLING SYSTEM WITH ALEXIS W...

K113496 is the FDA 510(k) clearance for VIRTURE MALE SLING SYSTEM WITH ALEXIS W... by Coloplast A/S. It is a Class 2 Gastroenterology & Urology device (product code OTM) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K113496 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
81d
Days
Class 2
Risk

K113496 is an FDA 510(k) clearance for the VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT. 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 February 14, 2012 after a review of 81 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. 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 Coloplast A/S devices

Submission Details

510(k) Number K113496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2011
Decision Date February 14, 2012
Days to Decision 81 days
Submission Type Traditional
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
49d faster than avg
Panel avg: 130d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - OTM Mesh, Surgical, For Stress Urinary Incontinence, Male

All 8
Devices cleared under the same product code (OTM) and FDA review panel - the closest regulatory comparables to K113496.
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
K231891 · Coloplast · Sep 2023
AdVance XP Male Sling System
K211847 · Boston Scientific Corporation · Dec 2021
AdVance XP Male Sling
K182169 · Boston Scientific Corporation · Nov 2018
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
K111881 · Coloplast A/S · Aug 2011
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
K101297 · Coloplast A/S · Jun 2010
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
K091152 · Coloplast A/S · May 2009