Restorelle Polypropylene Mesh
FDA 510(k) K092207 · Mpathy Medical Devices, Inc.
510(k) numberK092207
Submission
- Device name
- Restorelle Polypropylene Mesh
- Applicant
- Mpathy Medical Devices, Inc.
Glasgow, GB - Received
- July 22, 2009
- Decision date
- August 4, 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 |
| 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 |
More from American Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K092203 | Omnisure Urethral Sling, Model OTK52OTN · Special | 08/12/2009SE |
| K091180 | Minitape Urethral SlingPAH · Special | 07/14/2009SE |
| K073647 | Minitape Extra Urethral SlingOTN · Special | 03/03/2008SE |
| K073646 | Minitape Urethral SlingPAH · Special | 02/25/2008SE |
| K053361 | Modification to: Minimesh Polypropylene MeshOTO · Special | 02/06/2006SE |
| K041632 | Minimesh Polypropylene MeshOTO · Traditional | 11/17/2004SE |
Questions and answers
When was Restorelle Polypropylene Mesh cleared by the FDA?
Restorelle Polypropylene Mesh (K092207) received a 510(k) decision of Substantially Equivalent on August 4, 2009, 13 days after the submission was received.
What is the product code of K092207?
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.