Cleared Traditional

VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT

K113496 · Coloplast A/S · Gastroenterology & Urology

Feb 2012

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K113496 is an FDA 510(k) clearance for the VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT, a Mesh, Surgical, For Stress Urinary Incontinence, Male (Class II — Special Controls, product code OTM), submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on February 14, 2012, 81 days after receiving the submission on November 25, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K113496 FDA.gov
FDA Decision	Cleared 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

Device Classification

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