VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
FDA 510(k) clearance K101297 · decided 2010-06-03
Clearance details
- K-number
- K101297
- Device name
- VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 2010-05-10
- Decision date
- 2010-06-03
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- OTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AdVance™ XP Male Sling System (720163-03) (K242960) | Boston Scientific Corporation | 2024-11-15 |
| Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (K231891) | Coloplast | 2023-09-25 |
| AdVance XP Male Sling System (K211847) | Boston Scientific Corporation | 2021-12-20 |
| AdVance XP Male Sling (K182169) | Boston Scientific Corporation | 2018-11-27 |
| VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT (K113496) | Coloplast A/S | 2012-02-14 |
| VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT (K111881) | Coloplast A/S | 2011-08-17 |
| VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 (K091152) | Coloplast A/S | 2009-05-07 |
| VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM (K082640) | Coloplast Manufacturing Us, LLC | 2008-10-17 |
| I-STOP TRANS OBTURATOR MALE SLING (K063079) | Cl Medical | 2006-11-07 |
| MALE REMEEX SYSTEM (K062341) | Specialities Remeex International, S.L. | 2006-11-02 |
| AMS MALE TRANSOBTURATOR SLING SYSTEM (K053371) | American Medical Systems, Inc. | 2006-02-03 |
Recalls involving this device
No recalls on record reference this clearance.