K130006 is an FDA 510(k) clearance for the BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS. This device is classified as a Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (Class III - Premarket Approval, product code PAI).
Submitted by Cook Biotech Incorporated (West Lafayetta, US). The FDA issued a Cleared decision on April 5, 2013, 93 days after receiving the submission on January 2, 2013.
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 And Uterine Prolapse Repair Completed Transvaginally..
| 510(k) Number | K130006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2013 |
| Decision Date | April 05, 2013 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PAI — Mesh, Surgical, Non-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 And Uterine Prolapse Repair Completed Transvaginally. |