Cleared Traditional

RESTORELLE POLYPROPYLENE Y MESH

K112322 · Coloplast A/S · Obstetrics & Gynecology

May 2012

Decision

279d

Days

Class 2

Risk

About This 510(k) Submission

K112322 is an FDA 510(k) clearance for the RESTORELLE POLYPROPYLENE Y 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 May 17, 2012, 279 days after receiving the submission on August 12, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K112322 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2011
Decision Date	May 17, 2012
Days to Decision	279 days
Submission Type	Traditional
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.