OTP — Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Class III
Classification Details
- Product Code
- OTP
- Device Class
- Class III
- Regulation Number
- 884.5980
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- Yes
Definition
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K122459 | boston scientific corporation | PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYS | December 13, 2012 |
| K121612 | american medical systems | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION | July 20, 2012 |
| K112842 | american medical systems | AMS ELEVATE PC | October 25, 2011 |
| K103426 | boston scientific | LITE PELVIC FLOOR REPAIR KITS | September 14, 2011 |
| K112386 | coloplast | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM | September 8, 2011 |
| K102815 | neomedic international | SURELIFT PROLAPSE SYSTEM | July 7, 2011 |
| K111118 | american medical systems | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR S | July 1, 2011 |
| K092207 | mpathy medical devices | RESTORELLE POLYPROPYLENE MESH | August 4, 2009 |
| K083499 | coloplast | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS | May 8, 2009 |
| K091131 | boston scientific | PELVIC FLOOR REPAIR SYSTEM | May 8, 2009 |
| K090713 | american medical systems | ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR | April 2, 2009 |
| K083722 | caldera medical | ASCEND | March 31, 2009 |
| K083839 | c.r. bard | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM | January 15, 2009 |
| K082677 | american medical systems | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | December 23, 2008 |
| K082387 | american medical systems | APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PE | December 4, 2008 |
| K082730 | american medical systems | AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS E | November 26, 2008 |
| K081710 | american medical systems | APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE | October 15, 2008 |
| K082571 | c.r. bard | AVAULTA SUPPORT SYSTEM | September 30, 2008 |
| K081048 | boston scientific | PINNACLE PELVIC FLOOR REPAIR KIT II | August 22, 2008 |
| K071512 | ethicon | GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS | May 15, 2008 |