Panels › General, Plastic Surgery › Product code OTN · Class 2
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Regulation 878.3300
1510(k)s in 12 months (66 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OTN
| Company | 510(k)s | Recalls |
|---|---|---|
| American Medical Systems | 14 | 1 |
| Caldera Medical | 8 | 0 |
| ETHICON, Inc. | 6 | 0 |
| Boston Scientific | 5 | 0 |
| Mentor Corp. | 4 | 0 |
| Island Biosurgical, Inc. | 3 | 0 |
| Urocure, LLC | 3 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Generic Medical Device, Inc. | 2 | 0 |
| Influence, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | American Medical Systems, Inc. AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide.
The Monarc + and Monarc C Terminated |
OTN | K051530 K131229 |
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