K083499 is an FDA 510(k) clearance for the EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS. 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 A/S (Minneapolis, US). The FDA issued a Cleared decision on May 8, 2009, 164 days after receiving the submission on November 25, 2008.
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 | K083499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2008 |
| Decision Date | May 08, 2009 |
| Days to Decision | 164 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 |