OTM — Mesh, Surgical, For Stress Urinary Incontinence, Male Class II
FDA product code OTM covers "Mesh, Surgical, For Stress Urinary Incontinence, Male", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OTM
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
surgical treatment of male stress urinary incontinence post-prostatectomy
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242960 | boston scientific corporation | AdVance XP Male Sling System (720163-03) | November 15, 2024 |
| K231891 | coloplast | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | September 25, 2023 |
| K211847 | boston scientific corporation | AdVance XP Male Sling System | December 20, 2021 |
| K182169 | boston scientific corporation | AdVance XP Male Sling | November 27, 2018 |
| K113496 | coloplast | VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT | February 14, 2012 |
| K111881 | coloplast | VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT | August 17, 2011 |
| K101297 | coloplast | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 | June 3, 2010 |
| K091152 | coloplast | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 | May 7, 2009 |
| K082640 | coloplast manufacturing us | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM | October 17, 2008 |
| K063079 | cl medical | I-STOP TRANS OBTURATOR MALE SLING | November 7, 2006 |
| K062341 | specialities remeex international, s.l | MALE REMEEX SYSTEM | November 2, 2006 |
| K053371 | american medical systems | AMS MALE TRANSOBTURATOR SLING SYSTEM | February 3, 2006 |