Tepha, Inc.
Lexington, MA, US
Tepha, Inc. appears in FDA device records in Lexington, MA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Tepha, Inc. between 2007 and 2024. The busiest year on record is 2008, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2021 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233999 | GalaFLEX LITE Scaffold | OOD | Substantially Equivalent | |
| K202425 | SurgiLattice scaffold | OOD | Substantially Equivalent | |
| K211307 | GalaSTITCH Absorbable Monofilament Suture | NWJ | Substantially Equivalent | |
| K162922 | GalaFORM 3D | OOD | Substantially Equivalent | |
| K161092 | GalaSHAPE 3D | OOD | Substantially Equivalent | |
| K140533 | GALAFLEX MESH | OOD | Substantially Equivalent | |
| K132348 | TEPHAFLEX BRAIDED SUTURE | NWJ | Substantially Equivalent | |
| K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT | OOD | Substantially Equivalent | |
| K113723 | TEPHAFLEX MESH | OOD | Substantially Equivalent | |
| K113721 | TEPHAFLEX LIGHT MESH | OOD | Substantially Equivalent | |
| K111946 | TEPHAFLEX MESH | OOD | Substantially Equivalent | |
| K101287 | TEPHAFLEX COMPOSITE MESH | OWT | Substantially Equivalent | |
| K091633 | TEPHAFLEX SURGICAL FILM | OOD | Substantially Equivalent | |
| K082178 | TEPHAFLEX ABSORBABLE SUTURE | NWJ | Substantially Equivalent | |
| K081099 | TEPHAFLEX ABSORBABLE SUTURE | NWJ | Substantially Equivalent | |
| K072520 | TEPHAFLEX SURGICAL FILM | FTL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain