Lite Pelvic Floor Repair Kits
FDA 510(k) K103426 · Boston Scientific Corp
510(k) numberK103426
Submission
- Device name
- Lite Pelvic Floor Repair Kits
- Applicant
- Boston Scientific Corp
Marlboro, MA, US - Received
- November 22, 2010
- Decision date
- September 14, 2011
- 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 |
|---|---|---|---|
| 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 |
| 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 Lite Pelvic Floor Repair Kits cleared by the FDA?
Lite Pelvic Floor Repair Kits (K103426) received a 510(k) decision of Substantially Equivalent on September 14, 2011, 296 days after the submission was received.
What is the product code of K103426?
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.