PAG · Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | PAG |
|---|---|
| Device Name | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090688 | COOK UROLOGICAL GRAFT | Cook Biotech, Inc. | Jul 10, 2009 | SESE |
| K050445 | AMS COLLAGEN DERMAL MATRIX | American Medical Systems, Inc. | Jun 17, 2005 | SESE |
| K042949 | PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) | C.R. Bard, Inc. | Nov 9, 2004 | SESE |
| K031295 | BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM | C.R. Bard, Inc. | May 15, 2003 | SESE |
| K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Brennen Medical, Inc. | Mar 7, 2003 | SESE |
| K020654 | STRATASIS SLING KIT | Cook Biotech, Inc. | Apr 9, 2002 | SESE |
| K993459 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Advanced Uroscience, Inc. | Nov 5, 1999 | SESE |
| K992159 | SURGISIS SLING | Cook Biotech, Inc. | Sep 23, 1999 | SESE |
| K982403 | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Brennen Medical, Inc. | Sep 22, 1998 | SESE |
Top Applicants
- Cook Biotech, Inc. — 3 clearances
- Brennen Medical, Inc. — 2 clearances
- C.R. Bard, Inc. — 2 clearances
- Advanced Uroscience, Inc. — 1 clearance
- American Medical Systems, Inc. — 1 clearance
