K112322 is an FDA 510(k) clearance for the RESTORELLE POLYPROPYLENE Y MESH. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.3300. Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy..
| 510(k) Number | K112322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |