FDA 510(k) Applications Submitted by Tepha, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K161092 |
04/18/2016 |
GalaSHAPE 3D |
Tepha, Inc. |
| K162922 |
10/18/2016 |
GalaFORM 3D |
TEPHA, INC. |
| K211307 |
04/29/2021 |
GalaSTITCH Absorbable Monofilament Suture |
Tepha, Inc. |
| K202425 |
08/25/2020 |
SurgiLattice scaffold |
Tepha, Inc. |
| K072520 |
09/07/2007 |
TEPHAFLEX SURGICAL FILM |
TEPHA, INC. |
| K130326 |
02/08/2013 |
TEPHAFLEX MELTBLOWN CONSTRUCT |
TEPHA, INC. |
| K140533 |
03/04/2014 |
GALAFLEX MESH |
TEPHA, INC. |
| K070894 |
03/30/2007 |
TEPHAFLEX SURGICAL MESH |
TEPHA, INC. |
| K081099 |
04/17/2008 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
| K101287 |
05/07/2010 |
TEPHAFLEX COMPOSITE MESH |
TEPHA, INC. |
| DEN060003 |
05/12/2006 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
| K091633 |
06/04/2009 |
TEPHAFLEX SURGICAL FILM |
TEPHA, INC. |
| K111946 |
07/08/2011 |
TEPHAFLEX MESH |
TEPHA, INC. |
| K132348 |
07/29/2013 |
TEPHAFLEX BRAIDED SUTURE |
TEPHA, INC. |
| K082178 |
08/01/2008 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
| K113721 |
12/19/2011 |
TEPHAFLEX LIGHT MESH |
TEPHA, INC. |
| K113723 |
12/19/2011 |
TEPHAFLEX MESH |
TEPHA, INC. |
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