Tepha, Inc.: FDA clearances and approvals
Tepha, Inc. has 17 FDA 510(k) clearances (first 2007, latest 2024), plus 1 De Novo decision, across 4 product codes in 1 review panel. Median 510(k) review time: 83 days. Since 2017 its median was 120 days, against 111 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 58 |
| 2013 | 2 | 63 |
| 2014 | 1 | 78 |
| 2015 | 0 | — |
| 2016 | 1 | 127 |
| 2017 | 1 | 128 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 194 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 113 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Tepha, Inc.'s cleared 510(k)s took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OOD | Surgical Film | 11 | 11 |
| NWJ | Suture, Recombinant Technology | 5 | 4 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| OWT | Mesh, Surgical, Absorbable, Abdominal Hernia | 1 | 1 |
Review panels
Most recent Tepha, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233999 | GalaFLEX LITE Scaffold | OOD | 2024-04-09 | 113 |
| K202425 | SurgiLattice scaffold | OOD | 2021-08-19 | 359 |
| K211307 | GalaSTITCH Absorbable Monofilament Suture | NWJ | 2021-05-27 | 28 |
| K162922 | GalaFORM 3D | OOD | 2017-02-23 | 128 |
| K161092 | GalaSHAPE 3D | OOD | 2016-08-23 | 127 |
| K140533 | GALAFLEX MESH | OOD | 2014-05-21 | 78 |
| K132348 | TEPHAFLEX BRAIDED SUTURE | NWJ | 2013-09-05 | 38 |
| K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT | OOD | 2013-05-07 | 88 |
| K113723 | TEPHAFLEX MESH | OOD | 2012-02-15 | 58 |
| K113721 | TEPHAFLEX LIGHT MESH | OOD | 2012-02-15 | 58 |
7 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN060003 | De Novo | Suture, Recombinant Technology | 2007-02-08 |
Recalls
openFDA lists no recalls under a recalling firm named Tepha, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tepha, Inc. have?
Tepha, Inc. has 17 FDA 510(k) clearances (first 2007, latest 2024), plus 1 De Novo decision, across 4 product codes in 1 review panel.
How long does FDA take to clear Tepha, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tepha, Inc.'s cleared 510(k)s is 83 days. Since 2017: 120 days, versus 111 days for all cleared 510(k)s in the same product codes.
What devices does Tepha, Inc. make?
Its most frequent FDA product codes are OOD (Surgical Film, 11); NWJ (Suture, Recombinant Technology, 5); FTL (Mesh, Surgical, Polymeric, 1).
Has Tepha, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tepha, Inc. Related entities may recall under other names.
Next steps
- See all 17 Tepha, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OOD, Tepha, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.