Tva Medical, Inc.: FDA clearances and approvals
Tva Medical, Inc. has 1 FDA 510(k) clearance (first 2016, latest 2016), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time: 48 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 48 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| PQK | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | 1 | 0 |
Review panels
Most recent Tva Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162656 | ESU-1 Electrosurgical Generator | GEI | 2016-11-10 | 48 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160006 | De Novo | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | 2018-06-22 |
Recalls
openFDA lists no recalls under a recalling firm named Tva Medical, 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 Tva Medical, Inc. have?
Tva Medical, Inc. has 1 FDA 510(k) clearance (first 2016, latest 2016), plus 1 De Novo decision, across 2 product codes in 2 review panels.
How long does FDA take to clear Tva Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tva Medical, Inc.'s cleared 510(k)s is 48 days.
What devices does Tva Medical, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); PQK (Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access, 1).
Has Tva Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tva Medical, Inc. Related entities may recall under other names.
Next steps
- See all 1 Tva Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Tva Medical, 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.