Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System
FDA 510(k) K083839 · C.R. Bard, Inc.
510(k) numberK083839
Submission
- Device name
- Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- December 23, 2008
- Decision date
- January 15, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OTP – Mesh, Surgical, 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 or uterine prolapse repair performed transvaginally
Other 510(k)s with product code OTP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122459 | Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemOTP · Abbreviated | Boston Scientific Corporation | 12/13/2012SE |
| K121612 | Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationOTP · Special | American Medical Systems | 07/20/2012SE |
| K112842 | Ams Elevate PCOTP · Special | American Medical Systems, Inc. | 10/25/2011SE |
| K103426 | Lite Pelvic Floor Repair KitsOTP · Abbreviated | Boston Scientific Corp | 09/14/2011SE |
| K112386 | Exair Anterior and Posterior Prolapse Repair SystemOTP · Special | Coloplast Corp. | 09/08/2011SE |
| K102815 | Surelift Prolapse SystemOTP · Traditional | Neomedic International | 07/07/2011SE |
| K111118 | Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System…OTP · Special | American Medical Systems | 07/01/2011SE |
| K092207 | Restorelle Polypropylene MeshOTP · Special | Mpathy Medical Devices, Inc. | 08/04/2009SE |
| K091131 | Pelvic Floor Repair SystemOTP · Abbreviated | Boston Scientific | 05/08/2009SE |
| K083499 | Exair Anterior and Posterior Prolapse Repair SystemsOTP · Traditional | Coloplast A/S | 05/08/2009SE |
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Questions and answers
When was Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System cleared by the FDA?
Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System (K083839) received a 510(k) decision of Substantially Equivalent on January 15, 2009, 23 days after the submission was received.
What is the product code of K083839?
The FDA product code is OTP – Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, a Class III (high risk) device regulated under 21 CFR 884.5980.