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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2013 | Coloplast Manufacturing US, LLC Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark. Terminated |
OTO | K122440 |
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