Cleared Special

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020

K101297 · Coloplast A/S · Gastroenterology & Urology

Jun 2010

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K101297 is an FDA 510(k) clearance for the VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020, 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 June 3, 2010, 24 days after receiving the submission on May 10, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K101297 FDA.gov
FDA Decision	Cleared 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

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