Cleared Special

RESTORELLE Y CONTOUR

K123914 · Coloplast A/S · Obstetrics & Gynecology

Mar 2013

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K123914 is an FDA 510(k) clearance for the RESTORELLE Y CONTOUR, a Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (Class II — Special Controls, product code OTO), submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on March 5, 2013, 76 days after receiving the submission on December 19, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K123914 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2012
Decision Date	March 05, 2013
Days to Decision	76 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	OTO — Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy.