OTM · Mesh, Surgical, For Stress Urinary Incontinence, Male
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OTM |
|---|---|
| Device Name | Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242960 | AdVance XP Male Sling System (720163-03) | Boston Scientific Corporation | Nov 15, 2024 | SESE |
| K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast | Sep 25, 2023 | SESK |
| K211847 | AdVance XP Male Sling System | Boston Scientific Corporation | Dec 20, 2021 | SESE |
| K182169 | AdVance XP Male Sling | Boston Scientific Corporation | Nov 27, 2018 | SESE |
| K113496 | VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT | Coloplast A/S | Feb 14, 2012 | SESE |
| K111881 | VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT | Coloplast A/S | Aug 17, 2011 | SESE |
| K101297 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 | Coloplast A/S | Jun 3, 2010 | SESE |
| K091152 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 | Coloplast A/S | May 7, 2009 | SESE |
| K082640 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM | Coloplast Manufacturing Us, LLC | Oct 17, 2008 | SESE |
| K063079 | I-STOP TRANS OBTURATOR MALE SLING | Cl Medical | Nov 7, 2006 | SESE |
| K062341 | MALE REMEEX SYSTEM | Specialities Remeex International, S.L. | Nov 2, 2006 | SESE |
| K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM | American Medical Systems, Inc. | Feb 3, 2006 | SESE |
Top Applicants
- Coloplast A/S — 4 clearances
- Boston Scientific Corporation — 3 clearances
- American Medical Systems, Inc. — 1 clearance
- Cl Medical — 1 clearance
- Coloplast — 1 clearance
