Panels › General, Plastic Surgery › Product code OTO · Class 2
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Regulation 878.3300
0510(k)s in 12 months (23 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OTO
| Company | 510(k)s | Recalls |
|---|---|---|
| Caldera Medical | 5 | 0 |
| American Medical Systems | 3 | 0 |
| Coloplast Corp. | 3 | 0 |
| Coloplast A/S | 3 | 0 |
| Boston Scientific Corp | 2 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Mpathy Medical Devices, Ltd. | 2 | 0 |
| Coloplast Manufacturing US, LLC | 0 | 1 |
| ETHICON, Inc. | 1 | 0 |
| Gynecare, A Div. of Ethicon, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2017 | K171271 | Polyform Synthetic Mesh Boston Scientific Corporation | OTO |
| Apr 6, 2015 | K150023 | Vertessa Lite Y-Mesh Caldera Medical, Inc. | OTO |
| Apr 6, 2015 | K150016 | Vertessa Lite Caldera Medical, Inc. | OTO |
| Feb 12, 2014 | K140116 | RESTORELLE Y CONTOUR MESH Coloplast A/S | OTO |
| Aug 2, 2013 | K132061 | RESTORELLE M, RESTORELLE XL Coloplast Corp. | OTO |
| Apr 25, 2013 | K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH Caldera Medical, Inc. | OTO |
| Mar 5, 2013 | K123914 | RESTORELLE Y CONTOUR Coloplast A/S | OTO |
| Feb 21, 2013 | K123337 | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM Caldera Medical | OTO |
| Dec 18, 2012 | K122968 | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 Coloplast Corp. | OTO |
| Dec 18, 2012 | K122794 | UPSYLON Y MESH Boston Scientific Corp | OTO |
| Nov 19, 2012 | K122440 | RESTORELLE L Coloplast Corp. | OTO |
| Oct 16, 2012 | K121805 | AMS LARGE PORE POLYPROPHLENE MESH American Medical Systems | OTO |
| Jun 11, 2012 | K113205 | ARTISYN Y-SHAPED MESH ETHICON, Inc. | OTO |
| May 17, 2012 | K112322 | RESTORELLE POLYPROPYLENE Y MESH Coloplast A/S | OTO |
| May 10, 2012 | K120327 | VERTESSA Caldera Medical, Inc. | OTO |
| Apr 1, 2011 | K101722 | ALYTE Y-MESH GRAFT C.R. Bard, Inc. | OTO |
| Nov 10, 2009 | K090739 | BARD SACROCOLPOPEXY GRAFT C.R. Bard, Inc. | OTO |
| Feb 6, 2006 | K053361 | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH Mpathy Medical Devices, Ltd. | OTO |
| Aug 3, 2005 | K051485 | AMS PELVIC FLOOR REPAIR SYSTEM American Medical Systems, Inc. | OTO |
| Jun 17, 2005 | K051245 | POLYFORM SYNTHETIC MESH Proxy Biomedical , Ltd. | OTO |
| Nov 17, 2004 | K041632 | MINIMESH POLYPROPYLENE MESH Mpathy Medical Devices, Ltd. | OTO |
| Jan 8, 2002 | K013718 | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR Gynecare, A Div. of Ethicon, Inc. | OTO |
| Apr 9, 2001 | K010931 | AMS SACRAL COLPOPEXY SLING, MODEL 72403501 American Medical Systems, Inc. | OTO |
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