Cleared Special

RESTORELLE Y CONTOUR MESH

K140116 · Coloplast A/S · Obstetrics & Gynecology

Feb 2014

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K140116 is an FDA 510(k) clearance for the RESTORELLE Y CONTOUR MESH, 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 February 12, 2014, 27 days after receiving the submission on January 16, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K140116 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2014
Decision Date	February 12, 2014
Days to Decision	27 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.