Identifiers
- 510(k) Number
- K082571 FDA 510(k)
- FDA Product Code
- OTP 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 Avaulta Support System is a synthetic, surgical mesh device classified as a urogynecologic implant for transvaginal placement. It is designed to provide tissue reinforcement and stabilization of pelvic floor fascial structures in cases of vaginal wall prolapse, functioning as either mechanical support or bridging material for fascial defects.
This device is supplied as a sterile, single-use, permanent implant intended for surgical correction of anterior or posterior vaginal wall prolapse. It features a soft knit section for compliant organ support and reinforced knit arms for tension-free fixation. Authorized under FDA 510(k) clearance (K082571) with a classification as Class III, the system adheres to regulatory standards for urogynecologic mesh implants.
Frequently asked questions
What types of vaginal wall prolapse does the Avaulta Support System address, and how does it function in these cases?
The Avaulta Support System is designed specifically for surgical correction of anterior or posterior vaginal wall prolapse. It functions as a synthetic mesh implant that provides tissue reinforcement and stabilization of pelvic floor fascial structures. The device acts as either a mechanical support for weakened tissues or as bridging material to fill defects caused by prolapse, ensuring tension-free fixation through reinforced knit arms while offering compliant organ support via its soft knit section.
Is the Avaulta Support System intended for reuse, or is it meant to be implanted permanently as a single-use device?
The Avaulta Support System is sterile and intended for single-use only, with the implant designed as a permanent surgical device. It is not meant for reuse, as its purpose is to provide long-term reinforcement and stabilization of pelvic floor structures post-implantation.
What regulatory pathway was followed for FDA clearance of the Avaulta Support System, and which advisory committee was involved?
The Avaulta Support System received FDA 510(k) clearance under the classification of Class III, with a Special 510(k) review. The submission was evaluated by the Obstetrics/Gynecology (OB) Advisory Committee, reflecting its focus on urogynecologic applications. The clearance was granted on September 30, 2008, following a determination of substantial equivalence to a predicate device.
How is the Avaulta Support System packaged and prepared for surgical use?
The Avaulta Support System is supplied in a sterile, single-use package, ensuring it is ready for immediate surgical implantation without additional sterilization. The packaging maintains sterility until the device is opened for use, adhering to medical device standards for sterile surgical implants.
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. Sources consulted: Avaulta Support System/Avaulta Plus Biosynthetic Support System ..., AVAULTA SUPPORT SYSTEM (K082571) — FDA 510 (k) | Innolitics, AVAULTA SUPPORT SYSTEM (K082571) - FDA 510 (k), Avaulta Support System - BEUDAMED, AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIO... (K063712) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082571 | Class III | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K082571 24 fields · synced Sep 18, 2026