Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts
FDA 510(k) K130006 · Cook Biotech Incorporated
510(k) numberK130006
Submission
- Device name
- Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts
- Applicant
- Cook Biotech Incorporated
West Lafayette, IN, US - Received
- January 2, 2013
- Decision date
- April 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAI – Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 884.5980
- Specialty
- Obstetrics/Gynecology
- Implant
- Yes
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.
Other 510(k)s with product code PAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…PAI · Special | Tissue Science Laboratories, Plc | 03/09/2005SE |
More from Tissue Science Laboratories, Plc
| 510(k) | Device | Decision |
|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…KHJ · Traditional | 05/24/2024SE |
| K201000 | Biodesign Staple Line ReinforcementFTM · Traditional | 07/13/2020SE |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…OXN · Traditional | 12/27/2019SE |
| K171817 | Biodesign Diaphragmatic Hernia GraftFTM · Traditional | 03/13/2018SE |
| K162934 | Biodesign Parastomal Hernia Repair GraftFTM · Traditional | 07/10/2017SE |
| K170016 | Biodesign Fistula PlugFTM · Traditional | 06/21/2017SE |
| K170945 | Biodesign Staple Line ReinforcementOXE · Special | 04/28/2017SE |
| K161762 | DynaMatrix/Dynamatrix PlusNPL · Special | 01/13/2017SE |
| K162741 | AxoGuard Nerve ConnectorJXI · Special | 10/31/2016SE |
| K160136 | Flowable Wound MatrixKGN · Traditional | 09/28/2016SE |
Questions and answers
When was Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts cleared by the FDA?
Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts (K130006) received a 510(k) decision of Substantially Equivalent on April 5, 2013, 93 days after the submission was received.
What is the product code of K130006?
The FDA product code is PAI – Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, a Class III (high risk) device regulated under 21 CFR 884.5980.