Estech, Inc.: FDA clearances and approvals
Estech, Inc. has 7 FDA 510(k) clearances (first 1999, latest 2013), across 4 product codes in 2 review panels. Median 510(k) review time: 57 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 11 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 | 3 | 3 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
Review panels
Most recent Estech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133017 | ESTECH COBRA(R) GENESIS BIPOLAR CLAMP | GEI | 2013-10-07 | 11 |
| K053021 | ESTECH CLEARVIEW MV ATRIAL DEPRESSOR | DTS | 2006-01-26 | 92 |
| K052081 | REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA | DWF | 2005-12-16 | 136 |
| K051749 | COBRA SURGICAL SYSTEM | GEI | 2005-09-13 | 76 |
| K041599 | COBRA ADHERE SURGICAL SYSTEM | GEI | 2004-07-27 | 43 |
| K032632 | REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH | DWF | 2003-10-22 | 57 |
| K990573 | ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA | DXC | 1999-03-11 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Estech, 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 Estech, Inc. have?
Estech, Inc. has 7 FDA 510(k) clearances (first 1999, latest 2013), across 4 product codes in 2 review panels.
How long does FDA take to clear Estech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Estech, Inc.'s cleared 510(k)s is 57 days.
What devices does Estech, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2); DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass, 1).
Has Estech, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Estech, Inc. Related entities may recall under other names.
Next steps
- See all 7 Estech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Estech, 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.