FDA Product Code
FDA Product Code OOD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233999 | GalaFLEX LITE Scaffold | Tepha, Inc. | 2024-04-09 | Traditional | PDF ↗ |
| K202425 | SurgiLattice scaffold | Tepha, Inc. | 2021-08-19 | Traditional | PDF ↗ |
| K162922 | GalaFORM 3D | Tepha, Inc. | 2017-02-23 | Traditional | PDF ↗ |
| K161424 | Phasix Mesh | C.R. Bard, Inc. | 2016-09-29 | Traditional | PDF ↗ |
| K161092 | GalaSHAPE 3D | Tepha, Inc. | 2016-08-23 | Traditional | PDF ↗ |
| K142818 | Phasix Mesh | C. R. Bard | 2015-03-31 | Traditional | PDF ↗ |
| K140533 | GALAFLEX MESH | Tepha, Inc. | 2014-05-21 | Traditional | PDF ↗ |
| K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT | Tepha, Inc. | 2013-05-07 | Traditional | PDF ↗ |
| K113723 | TEPHAFLEX MESH | Tepha, Inc. | 2012-02-15 | Traditional | PDF ↗ |
| K113721 | TEPHAFLEX LIGHT MESH | Tepha, Inc. | 2012-02-15 | Traditional | PDF ↗ |
| K111946 | TEPHAFLEX MESH | Tepha, Inc. | 2011-09-26 | Traditional | PDF ↗ |
| K091633 | TEPHAFLEX SURGICAL FILM | Tepha, Inc. | 2009-08-07 | Traditional | PDF ↗ |
| K070894 | TEPHAFLEX SURGICAL MESH | Tepha, Inc. | 2007-04-13 | Traditional | PDF ↗ |
Product code OOD · Class II · General, Plastic Surgery. Data: openFDA.