FDA Product Code
FDA Product Code PAG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K090688 | COOK UROLOGICAL GRAFT | Cook Biotech, Inc. | 2009-07-10 | Traditional | PDF ↗ |
| K050445 | AMS COLLAGEN DERMAL MATRIX | American Medical Systems, Inc. | 2005-06-17 | Traditional | PDF ↗ |
| K042949 | PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) | C.R. Bard, Inc. | 2004-11-09 | Traditional | PDF ↗ |
| K031295 | BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM | C.R. Bard, Inc. | 2003-05-15 | Traditional | PDF ↗ |
| K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Brennen Medical, Inc. | 2003-03-07 | Special | PDF ↗ |
| K020654 | STRATASIS SLING KIT | Cook Biotech, Inc. | 2002-04-09 | Traditional | PDF ↗ |
| K993459 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Advanced Uroscience, Inc. | 1999-11-05 | Special | PDF ↗ |
| K992159 | SURGISIS SLING | Cook Biotech, Inc. | 1999-09-23 | Traditional | PDF ↗ |
| K982403 | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Brennen Medical, Inc. | 1998-09-22 | Traditional | PDF ↗ |
Product code PAG · Class II · General, Plastic Surgery. Data: openFDA.