Panels › General, Plastic Surgery › Product code OTM · Class 2
Mesh, Surgical, For Stress Urinary Incontinence, Male
Regulation 878.3300
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OTM
| Company | 510(k)s | Recalls |
|---|---|---|
| Coloplast A/S | 4 | 0 |
| Boston Scientific Corporation | 3 | 0 |
| American Medical Systems, Inc. | 1 | 1 |
| Cl Medical | 1 | 0 |
| Coloplast | 1 | 0 |
| Coloplast Manufacturing Us, LLC | 1 | 0 |
| Specialities Remeex International, S.L. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | American Medical Systems, Inc. AdVance"Male Sling System, REF 720088-01 &
AdVance" XP Male Sling System REF 720163-01
(not commercially available in the US)
The AdVance Male Sling System consists of two, sterile single-use surgic Terminated |
OTM | K053371 |
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