Product code OTO
- Device name
- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- OB
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171271 | Polyform Synthetic Mesh | Boston Scientific Corporation | 2017-12-15 |
| K150023 | Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2015-04-06 |
| K150016 | Vertessa Lite | Caldera Medical, Inc. | 2015-04-06 |
| K140116 | RESTORELLE Y CONTOUR MESH | Coloplast A/S | 2014-02-12 |
| K132061 | RESTORELLE M, RESTORELLE XL | Coloplast Corp. | 2013-08-02 |
| K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH | Caldera Medical, Inc. | 2013-04-25 |
| K123914 | RESTORELLE Y CONTOUR | Coloplast A/S | 2013-03-05 |
| K123337 | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM | Caldera Medical | 2013-02-21 |
| K122968 | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 | Coloplast Corp. | 2012-12-18 |
| K122794 | UPSYLON Y MESH | Boston Scientific Corp | 2012-12-18 |
| K122440 | RESTORELLE L | Coloplast Corp. | 2012-11-19 |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | American Medical Systems | 2012-10-16 |
| K113205 | ARTISYN Y-SHAPED MESH | ETHICON, Inc. | 2012-06-11 |
| K112322 | RESTORELLE POLYPROPYLENE Y MESH | Coloplast A/S | 2012-05-17 |
| K120327 | VERTESSA | Caldera Medical, Inc. | 2012-05-10 |
| K101722 | ALYTE Y-MESH GRAFT | C.R. Bard, Inc. | 2011-04-01 |
| K090739 | BARD SACROCOLPOPEXY GRAFT | C.R. Bard, Inc. | 2009-11-10 |
| K053361 | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH | Mpathy Medical Devices, Ltd. | 2006-02-06 |
| K051485 | AMS PELVIC FLOOR REPAIR SYSTEM | American Medical Systems, Inc. | 2005-08-03 |
| K051245 | POLYFORM SYNTHETIC MESH | Proxy Biomedical , Ltd. | 2005-06-17 |
| K041632 | MINIMESH POLYPROPYLENE MESH | Mpathy Medical Devices, Ltd. | 2004-11-17 |
| K013718 | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR | Gynecare, A Div. of Ethicon, Inc. | 2002-01-08 |
| K010931 | AMS SACRAL COLPOPEXY SLING, MODEL 72403501 | American Medical Systems, Inc. | 2001-04-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00890594000056 | Desara Blue SL | Caldera Medical, Inc. | 2022-08-03 |
| 00890594000070 | Desara Blue SL | Caldera Medical, Inc. | 2022-08-03 |
| 10705031202795 | ARTISYN | Johnson & Johnson Medical GmbH | 2019-01-29 |
| 00890594000766 | Desara SL | Caldera Medical, Inc. | 2016-05-27 |
| 00890594000445 | Vertessa Lite Y 22x5x4cm | CALDERA MEDICAL, INC. | 2016-05-27 |
| 00890594000421 | Vertessa Lite Y-mesh 22x4x3cm | Caldera Medical, Inc. | 2016-05-27 |
| 00890594000384 | Vertessa Lite Strips 4x22cm | CALDERA MEDICAL, INC. | 2016-05-27 |
| 00890594000360 | Vertessa Lite 10x26cm | Caldera Medical, Inc. | 2016-05-27 |
| 00890594000643 | Vertessa Lite 10x22cm | CALDERA MEDICAL, INC. | 2016-05-27 |
| 00890594000698 | Desara Blue OV | CALDERA MEDICAL, INC. | 2016-05-27 |
| 00890594000735 | Desara Blue Short Suture Sling | Caldera Medical, Inc. | 2016-05-27 |
| 00890594000704 | Desara Blue OV | Caldera Medical, Inc. | 2016-05-27 |
| 00890594000452 | Vertessa Lite Y 22x5x4cm | Caldera Medical, Inc. | 2016-05-27 |
| 00890594000391 | Vertessa Lite Strips 4x22cm | Caldera Medical, Inc. | 2016-05-27 |
| 00890594000339 | Vertessa Lite 10x22cm | Caldera Medical, Inc. | 2016-05-27 |
| 00890594000728 | Desara Blue Short Suture Sling | CALDERA MEDICAL, INC. | 2016-05-27 |
| 00890594000674 | Desara Blue | Caldera Medical, Inc. | 2016-05-26 |
| 00890594000797 | Vertessa Lite Y-Mesh 26x5x4cm | Caldera Medical, Inc. | 2015-10-30 |
| 00890594000483 | Vertessa Lite Y-Mesh 26x4x3cm | Caldera Medical, Inc. | 2015-10-30 |
| 05708932483223 | Restorelle | Coloplast A/S | 2015-10-24 |
| 05708932483285 | Restorelle | Coloplast A/S | 2015-10-22 |
| 05708932483834 | Restorelle | Coloplast A/S | 2015-10-22 |
| 10705031218475 | ARTISYN | Johnson & Johnson International Inc. | 2015-09-24 |
| 10705031037731 | GYNECARE GYNEMESH | ETHICON, LLC | 2015-09-24 |
| 08714729845256 | Polyform™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729839224 | Polyform™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729839217 | Upsylon™ | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 10705031037748 | GYNECARE GYNEMESH | ETHICON, LLC | 2015-09-23 |
| 20705031037738 | GYNECARE GYNEMESH | ETHICON, LLC | 2015-09-23 |
| 00801741016165 | Alyte™ Y-Mesh Graft | C. R. Bard, Inc. | 2015-09-14 |