K112386 is an FDA 510(k) clearance for the EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM. This device is classified as a Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (Class III - Premarket Approval, product code OTP).
Submitted by Coloplast Corp. (Minneapolis, US). The FDA issued a Cleared decision on September 8, 2011, 21 days after receiving the submission on August 18, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5980. 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.
| 510(k) Number | K112386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2011 |
| Decision Date | September 08, 2011 |
| Days to Decision | 21 days |
| Submission Type | Special |
| 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 |