Company ยท US
Tepha, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2024. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2024 | K233999 | GalaFLEX LITE Scaffold Tepha, Inc. | OOD |
| Aug 19, 2021 | K202425 | SurgiLattice scaffold Tepha, Inc. | OOD |
| May 27, 2021 | K211307 | GalaSTITCH Absorbable Monofilament Suture Tepha, Inc. | NWJ |
| Feb 23, 2017 | K162922 | GalaFORM 3D Tepha, Inc. | OOD |
| Aug 23, 2016 | K161092 | GalaSHAPE 3D Tepha, Inc. | OOD |
| May 21, 2014 | K140533 | GALAFLEX MESH Tepha, Inc. | OOD |
| Sep 5, 2013 | K132348 | TEPHAFLEX BRAIDED SUTURE Tepha, Inc. | NWJ |
| May 7, 2013 | K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT Tepha, Inc. | OOD |
| Feb 15, 2012 | K113723 | TEPHAFLEX MESH Tepha, Inc. | OOD |
| Feb 15, 2012 | K113721 | TEPHAFLEX LIGHT MESH Tepha, Inc. | OOD |
| Sep 26, 2011 | K111946 | TEPHAFLEX MESH Tepha, Inc. | OOD |
| Aug 30, 2010 | K101287 | TEPHAFLEX COMPOSITE MESH Tepha, Inc. | OWT |
| Aug 7, 2009 | K091633 | TEPHAFLEX SURGICAL FILM Tepha, Inc. | OOD |
| Oct 30, 2008 | K082178 | TEPHAFLEX ABSORBABLE SUTURE Tepha, Inc. | NWJ |
| Jul 15, 2008 | K081099 | TEPHAFLEX ABSORBABLE SUTURE Tepha, Inc. | NWJ |
| Nov 29, 2007 | K072520 | TEPHAFLEX SURGICAL FILM Tepha, Inc. | FTL |
| Apr 13, 2007 | K070894 | TEPHAFLEX SURGICAL MESH Tepha, Inc. | OOD |
| Feb 8, 2007 | DEN060003 | TEPHAFLEX ABSORBABLE SUTURE Tepha, Inc. | NWJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2016 | Tepha Incorporated GalaSHAPE 3D; product code SH3D03, a medium size oval
GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where wea Terminated |
OOD | K161092 |