The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Virture Male Sling System With Alexis Wound Retractor Convenience Kit.
| Device ID | K113496 |
| 510k Number | K113496 |
| Device Name: | VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT |
| Classification | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Applicant | COLOPLAST A/S 1601 WEST RIVER RD NORTH Minneapolis, MN 55411 |
| Contact | Janell Colley |
| Correspondent | Janell Colley COLOPLAST A/S 1601 WEST RIVER RD NORTH Minneapolis, MN 55411 |
| Product Code | OTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-25 |
| Decision Date | 2012-02-14 |
| Summary: | summary |