510(k) K113496
- Device
- VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
- Applicant
- COLOPLAST A/S
- 510(k) number
- K113496
- Product code
- OTM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-02-14
- Date received
- 2011-11-25
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, For Stress Urinary Incontinence, Male
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANELL COLLEY
- Address
- 1601 W. River Rd. N. Plymouth MN US 55411 55411
FDA Registration Numbers#
- 3006621295
- 1828132
- 1000121056
- 2529647
- 3017791709
- 3005099803
- 2124215
- 3004838863
- 1225687
- 2183744
- 2125050
- 3010178296
Source Documents#
Other 510(k) Records For Product Code OTM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242960 | AdVance™ XP Male Sling System (720163-03) | Boston Scientific Corporation | 2024-11-15 |
| K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast | 2023-09-25 |
| K211847 | AdVance XP Male Sling System | Boston Scientific Corporation | 2021-12-20 |
| K182169 | AdVance XP Male Sling | Boston Scientific Corporation | 2018-11-27 |
| K111881 | VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT | Coloplast A/S | 2011-08-17 |
| K101297 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 | Coloplast A/S | 2010-06-03 |
| K091152 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 | Coloplast A/S | 2009-05-07 |
| K082640 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM | Coloplast Manufacturing Us, LLC | 2008-10-17 |
| K063079 | I-STOP TRANS OBTURATOR MALE SLING | Cl Medical | 2006-11-07 |
| K062341 | MALE REMEEX SYSTEM | Specialities Remeex International, S.L. | 2006-11-02 |
| K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM | American Medical Systems, Inc. | 2006-02-03 |
Legacy Summary#
summary
FDA Review#
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