K102815 is an FDA 510(k) clearance for the SURELIFT PROLAPSE SYSTEM, a Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (Class III — Premarket Approval, product code OTP), submitted by Neomedic International (Minneapolis, US). The FDA issued a Cleared decision on July 7, 2011, 282 days after receiving the submission on September 28, 2010. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5980.
| 510(k) Number | K102815 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 2010 |
| Decision Date | July 07, 2011 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | OTP — Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Device Class | Class III — Premarket Approval |
| CFR Regulation | 21 CFR 884.5980 |
| Definition | Tissue Reinforcement Of The Fibromuscular Layer Of The Pelvic Floor When Surgical Treatment Is Indicated; Procedures Include Anterior And Posterior Vaginal Wall Prolapse Repair And Vaginal Apical Or Uterine Prolapse Repair Performed Transvaginally |