OTO — Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed Class II
FDA product code OTO covers "Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OTO
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- OB
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K171271 | boston scientific corporation | Polyform Synthetic Mesh | December 15, 2017 |
| K150023 | caldera medical | Vertessa Lite Y-Mesh | April 6, 2015 |
| K150016 | caldera medical | Vertessa Lite | April 6, 2015 |
| K140116 | coloplast | RESTORELLE Y CONTOUR MESH | February 12, 2014 |
| K132061 | coloplast | RESTORELLE M, RESTORELLE XL | August 2, 2013 |
| K123028 | caldera medical | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH | April 25, 2013 |
| K123914 | coloplast | RESTORELLE Y CONTOUR | March 5, 2013 |
| K123337 | caldera medical | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM | February 21, 2013 |
| K122968 | coloplast | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 | December 18, 2012 |
| K122794 | boston scientific | UPSYLON Y MESH | December 18, 2012 |
| K122440 | coloplast | RESTORELLE L | November 19, 2012 |
| K121805 | american medical systems | AMS LARGE PORE POLYPROPHLENE MESH | October 16, 2012 |
| K113205 | ethicon | ARTISYN Y-SHAPED MESH | June 11, 2012 |
| K112322 | coloplast | RESTORELLE POLYPROPYLENE Y MESH | May 17, 2012 |
| K120327 | caldera medical | VERTESSA | May 10, 2012 |
| K101722 | c.r. bard | ALYTE Y-MESH GRAFT | April 1, 2011 |
| K090739 | c.r. bard | BARD SACROCOLPOPEXY GRAFT | November 10, 2009 |
| K053361 | mpathy medical devices | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH | February 6, 2006 |
| K051485 | american medical systems | AMS PELVIC FLOOR REPAIR SYSTEM | August 3, 2005 |
| K051245 | proxy biomedical | POLYFORM SYNTHETIC MESH | June 17, 2005 |