FDA Product Code
FDA Product Code OTM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242960 | AdVance XP Male Sling System (720163-03) | Boston Scientific Corporation | 2024-11-15 | Traditional | PDF ↗ |
| K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast | 2023-09-25 | Traditional | PDF ↗ |
| K211847 | AdVance XP Male Sling System | Boston Scientific Corporation | 2021-12-20 | Traditional | PDF ↗ |
| K182169 | AdVance XP Male Sling | Boston Scientific Corporation | 2018-11-27 | Traditional | PDF ↗ |
| K113496 | VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT | Coloplast A/S | 2012-02-14 | Traditional | PDF ↗ |
| K111881 | VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT | Coloplast A/S | 2011-08-17 | Traditional | PDF ↗ |
| K101297 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 | Coloplast A/S | 2010-06-03 | Special | PDF ↗ |
| K091152 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 | Coloplast A/S | 2009-05-07 | Special | PDF ↗ |
| K082640 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM | Coloplast Manufacturing Us, LLC | 2008-10-17 | Traditional | PDF ↗ |
| K063079 | I-STOP TRANS OBTURATOR MALE SLING | Cl Medical | 2006-11-07 | Traditional | PDF ↗ |
| K062341 | MALE REMEEX SYSTEM | Specialities Remeex International, S.L. | 2006-11-02 | Traditional | PDF ↗ |
| K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM | American Medical Systems, Inc. | 2006-02-03 | Traditional | PDF ↗ |
Product code OTM · Class II · General, Plastic Surgery. Data: openFDA.