Ams Elevate PC
FDA 510(k) K112842 · American Medical Systems, Inc.
510(k) numberK112842
Submission
- Device name
- Ams Elevate PC
- Applicant
- American Medical Systems, Inc.
Minnetonka, MN, US - Received
- September 29, 2011
- Decision date
- October 25, 2011
- 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 |
| 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 |
More from American Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K140679 | Sureflex Lithotripsy Laser FibersGEX · Traditional | 06/20/2014SE |
| K131229 | Sparc System and Monarc, Monarc, and Monarc C SystemsOTN · Special | 12/05/2013SE |
| K132655 | Retroarc Retropubic Sling SystemOTN · Traditional | 11/20/2013SE |
| K121805 | Ams Large Pore Polyprophlene MeshOTO · Traditional | 10/16/2012SE |
| K121641 | Miniarc Pro Single-Incision Sling SystemPAH · Traditional | 09/07/2012SE |
| K121612 | Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationOTP · Special | 07/20/2012SE |
| K120870 | Greenlight Moxy Fiber OpticGEX · Special | 06/15/2012SE |
| K111118 | Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System…OTP · Special | 07/01/2011SE |
| K100746 | Fiber OneGEX · Traditional | 06/11/2010SE |
| K100807 | Miniarc Precise Single-Incision Sling System Model: 720181, 720191PAH · Traditional | 06/07/2010SE |
Questions and answers
When was Ams Elevate PC cleared by the FDA?
Ams Elevate PC (K112842) received a 510(k) decision of Substantially Equivalent on October 25, 2011, 26 days after the submission was received.
What is the product code of K112842?
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.