Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K130006 FDA 510(k)
- FDA Product Code
- PAI FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5980 FDA 510(k)
- Regulation Number
- 884.5980 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts are a non-synthetic surgical mesh designed for urogynecologic use. Classified as a transvaginally placed device for pelvic organ prolapse repair, this graft is intended to provide structural support to weakened pelvic tissues.
These grafts are supplied in sterile form for single-use and are regulated under FDA 510(k) clearance (K130006) as a Class III device. They are intended for use in surgical settings by trained medical professionals, adhering to standard aseptic techniques. The product is available in specific sizes and configurations as referenced in the device specifications.
Frequently asked questions
What is the Biodesign Surgisis Anterior Posterior Pelvic Floor Graft primarily used for in clinical practice?
The Biodesign Surgisis Anterior Posterior Pelvic Floor Graft is designed specifically for urogynecologic use to provide structural support to weakened pelvic tissues during pelvic organ prolapse repair. It is intended for transvaginal placement by trained medical professionals to reinforce areas where pelvic organs may descend or prolapse, helping restore anatomical integrity.
Are these grafts meant for single-use or can they be reused after sterilization?
These grafts are explicitly supplied in a sterile form for single-use only. The packaging and labeling emphasize this to ensure patient safety and compliance with surgical best practices, as reuse could compromise sterility and integrity.
How are the Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts regulated in the U.S.?
The device is regulated under the FDA 510(k) clearance process (K130006) as a Class III medical device, with a decision classified as *Substantially Equivalent* to a predicate. It was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee and cleared for market distribution in 2013, adhering to traditional 510(k) pathways.
What types of sizes or configurations are available for the Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts?
While the exact sizes and configurations are not detailed in the provided data, the device is described as available in specific sizes and configurations tailored for urogynecologic pelvic organ prolapse repair. For precise sizing options, refer to the manufacturer’s technical documentation or consult Cook Biotech’s product catalog, as these details are critical for surgical planning.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130006 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Biotech Incorporated
Sources (1)
- FDA 510(k) K130006 24 fields · synced Oct 6, 2026