OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OTO |
|---|---|
| Device Name | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171271 | Polyform Synthetic Mesh | Boston Scientific Corporation | Dec 15, 2017 | SESE |
| K150023 | Vertessa Lite Y-Mesh | Caldera Medical, Inc. | Apr 6, 2015 | SESE |
| K150016 | Vertessa Lite | Caldera Medical, Inc. | Apr 6, 2015 | SESE |
| K140116 | RESTORELLE Y CONTOUR MESH | Coloplast A/S | Feb 12, 2014 | SESE |
| K132061 | RESTORELLE M, RESTORELLE XL | Coloplast Corp. | Aug 2, 2013 | SESE |
| K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH | Caldera Medical, Inc. | Apr 25, 2013 | SESE |
| K123914 | RESTORELLE Y CONTOUR | Coloplast A/S | Mar 5, 2013 | SESE |
| K123337 | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM | Caldera Medical | Feb 21, 2013 | SESE |
| K122968 | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 | Coloplast Corp. | Dec 18, 2012 | SESE |
| K122794 | UPSYLON Y MESH | Boston Scientific Corp | Dec 18, 2012 | SESE |
| K122440 | RESTORELLE L | Coloplast Corp. | Nov 19, 2012 | SESE |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | American Medical Systems | Oct 16, 2012 | SESE |
| K113205 | ARTISYN Y-SHAPED MESH | ETHICON, Inc. | Jun 11, 2012 | SESE |
| K112322 | RESTORELLE POLYPROPYLENE Y MESH | Coloplast A/S | May 17, 2012 | SESE |
| K120327 | VERTESSA | Caldera Medical, Inc. | May 10, 2012 | SESE |
| K101722 | ALYTE Y-MESH GRAFT | C.R. Bard, Inc. | Apr 1, 2011 | SESE |
| K090739 | BARD SACROCOLPOPEXY GRAFT | C.R. Bard, Inc. | Nov 10, 2009 | SESE |
| K053361 | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH | Mpathy Medical Devices, Ltd. | Feb 6, 2006 | SESE |
| K051485 | AMS PELVIC FLOOR REPAIR SYSTEM | American Medical Systems, Inc. | Aug 3, 2005 | SESE |
| K051245 | POLYFORM SYNTHETIC MESH | Proxy Biomedical , Ltd. | Jun 17, 2005 | SESE |
Top Applicants
- Caldera Medical, Inc. — 4 clearances
- Coloplast Corp. — 3 clearances
- Coloplast A/S — 3 clearances
- Mpathy Medical Devices, Ltd. — 2 clearances
- C.R. Bard, Inc. — 2 clearances
