Endoscopic Technologies, Inc. D/B/A Estech: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Endoscopic Technologies, Inc. D/B/A Estech” (first 2009, latest 2012), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 131 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 119 |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Endoscopic Technologies, Inc. D/B/A Estech 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113475 | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM | OCL | 2012-03-20 | 119 |
| K110913 | ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY | OCL | 2011-09-23 | 175 |
| K100224 | ESTECH COBRA BIPOLSR II | GEI | 2010-04-07 | 71 |
| K091542 | ESTECH EASYFLOW CANNULA WITH GUIDEWIRE | DWF | 2009-10-20 | 147 |
| K091350 | ESTECH HAWKEYE INTRODUCER SYSTEMS | GCJ | 2009-09-15 | 131 |
Recalls
openFDA lists no recalls under a recalling firm named Endoscopic Technologies, Inc. D/B/A Estech.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Endoscopic Technologies, Inc. (8 510(k)s)
- Endoscopic Concepts, Inc. (4 510(k)s)
- Endoscopic Surgical Products, Inc. (2 510(k)s)
- Endoscopic Innovations, Inc. (1 510(k)s)
- Endoscopic Surgical Accessories, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Endoscopic Technologies, Inc. D/B/A Estech?
FDA lists 5 510(k) clearances under the applicant name “Endoscopic Technologies, Inc. D/B/A Estech” (first 2009, latest 2012), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Endoscopic Technologies, Inc. D/B/A Estech?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endoscopic Technologies, Inc. D/B/A Estech is 131 days.
Which FDA product codes appear under Endoscopic Technologies, Inc. D/B/A Estech?
The most frequent FDA product codes under this applicant name are OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, 2); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 5 Endoscopic Technologies, Inc. D/B/A Estech clearances with predicates and recalls
- Run predicate analysis for product code OCL, Endoscopic Technologies, Inc. D/B/A Estech's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.