Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System
FDA 510(k) K122459 · Boston Scientific Corporation
510(k) numberK122459
Submission
- Device name
- Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- August 13, 2012
- Decision date
- December 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|---|
| 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 |
| K090713 | Elevate Prolapse Repair System with PC Coated Intepro Lite- Apical and Posterior…OTP · Special | American Medical Systems, Inc. | 04/02/2009SE |
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Questions and answers
When was Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System cleared by the FDA?
Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System (K122459) received a 510(k) decision of Substantially Equivalent on December 13, 2012, 122 days after the submission was received.
What is the product code of K122459?
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.