Cleared Traditional

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT

K111881 · Coloplast A/S · General Hospital

Aug 2011

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K111881 is an FDA 510(k) clearance for the VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR 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 August 17, 2011, 47 days after receiving the submission on July 1, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K111881 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2011
Decision Date	August 17, 2011
Days to Decision	47 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
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