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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2024 | K242960 | AdVance XP Male Sling System (720163-03) Boston Scientific Corporation | OTM |
| Sep 25, 2023 | K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit Coloplast | OTM |
| Dec 20, 2021 | K211847 | AdVance XP Male Sling System Boston Scientific Corporation | OTM |
| Nov 27, 2018 | K182169 | AdVance XP Male Sling Boston Scientific Corporation | OTM |
| Feb 14, 2012 | K113496 | VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT Coloplast A/S | OTM |
| Aug 17, 2011 | K111881 | VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT Coloplast A/S | OTM |
| Jun 3, 2010 | K101297 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 Coloplast A/S | OTM |
| May 7, 2009 | K091152 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 Coloplast A/S, DK | OTM |
| Oct 17, 2008 | K082640 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM Coloplast Manufacturing Us, LLC | OTM |
| Nov 7, 2006 | K063079 | I-STOP TRANS OBTURATOR MALE SLING Cl Medical, FR | OTM |
| Nov 2, 2006 | K062341 | MALE REMEEX SYSTEM Specialities Remeex International, S.L. | OTM |
| Feb 3, 2006 | K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM American Medical Systems, Inc. | OTM |
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