Avaulta Support System/Avaulta Plus Biosynthetic Support System
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K063712 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 designed for pelvic organ prolapse repair, classified as a transvaginally placed urogynecologic device. The Avaulta Plus variant incorporates a porous, acellular, crosslinked collagen sheet to act as a protective barrier between the mesh and mucosal tissue, providing additional biocompatibility.
This device is intended for single-use, sterile surgical applications in obstetrics and gynecology. Supplied as a Class III medical device under FDA 510(k) clearance (K063712), it is intended for transvaginal placement and is manufactured by C.R. Bard, Inc. The mesh is composed of nonabsorbable monofilament polypropylene, with the Avaulta Plus variant including an integrated collagen barrier.
Frequently asked questions
What is the primary clinical use for the Avaulta Support System and how does the Avaulta Plus variant differ in design?
The Avaulta Support System is designed specifically for transvaginal pelvic organ prolapse repair in obstetrics and gynecology. The Avaulta Plus variant includes an additional porous, acellular, crosslinked collagen sheet integrated into the mesh, serving as a protective barrier between the mesh and mucosal tissue to enhance biocompatibility and reduce tissue irritation.
Is the Avaulta Support System intended for reuse or single-use, and what does this mean for surgical planning?
The Avaulta Support System is explicitly intended for single-use only. This means each sterile package is designed for one surgical procedure, ensuring patient safety and reducing the risk of infection or contamination from repeated use. Clinicians should plan accordingly by using a fresh, sterile package for each patient.
What materials are used in the Avaulta Support System, and how does the Avaulta Plus variant differ compositionally?
The Avaulta Support System is made of nonabsorbable monofilament polypropylene mesh. The Avaulta Plus variant adds an integrated collagen barrier—a porous, acellular, crosslinked collagen sheet—to the polypropylene mesh, providing an extra layer of biocompatibility between the mesh and surrounding tissue.
How is the Avaulta Support System supplied, and what should clinicians consider regarding sterility and handling?
The Avaulta Support System is supplied as a sterile, single-use device. Clinicians should handle it using aseptic techniques to maintain sterility before and during surgery. The sterile packaging ensures it is ready for immediate use in the operating room without additional sterilization steps.
What regulatory pathway was followed for FDA clearance of the Avaulta Support System, and what does this mean for its use?
The Avaulta Support System was cleared through the FDA’s 510(k) pathway, specifically under Traditional review by the Obstetrics/Gynecology (OB) Advisory Committee. The clearance (K063712) confirms it is classified as a Class III device and is deemed substantially equivalent to a predicate device, meaning it meets FDA standards for safety and effectiveness as intended for transvaginal pelvic organ prolapse repair.
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 Solo Synthetic Support System, Avaulta Plus Biosynthetic ..., 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 | K063712 | Class III | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K063712 24 fields · synced Sep 18, 2026