Panels › General, Plastic Surgery › Product code PAG · Class 2
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Regulation 878.3300
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PAG
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Biotech, Inc. | 3 | 0 |
| Brennen Medical, Inc. | 2 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Advanced Uroscience, Inc. | 1 | 0 |
| American Medical Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2009 | K090688 | COOK UROLOGICAL GRAFT Cook Biotech, Inc. | PAG |
| Jun 17, 2005 | K050445 | AMS COLLAGEN DERMAL MATRIX American Medical Systems, Inc. | PAG |
| Nov 9, 2004 | K042949 | PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) C.R. Bard, Inc. | PAG |
| May 15, 2003 | K031295 | BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM C.R. Bard, Inc. | PAG |
| Mar 7, 2003 | K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX Brennen Medical, Inc. | PAG |
| Apr 9, 2002 | K020654 | STRATASIS SLING KIT Cook Biotech, Inc. | PAG |
| Nov 5, 1999 | K993459 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX Advanced Uroscience, Inc. | PAG |
| Sep 23, 1999 | K992159 | SURGISIS SLING Cook Biotech, Inc. | PAG |
| Sep 22, 1998 | K982403 | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX Brennen Medical, Inc. | PAG |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.