Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endoscopic Technologies, Inc. D/B/A Estech — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
131 daysmedian FDA review time
175 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113475 | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM | Endoscopic Technologies, Inc. D/B/A Estech | 2012-03-20 | 119 | 0 |
| K110913 | ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY | Endoscopic Technologies, Inc. D/B/A Estech | 2011-09-23 | 175 | 0 |
| K100224 | ESTECH COBRA BIPOLSR II | Endoscopic Technologies, Inc. D/B/A Estech | 2010-04-07 | 71 | 0 |
| K091542 | ESTECH EASYFLOW CANNULA WITH GUIDEWIRE | Endoscopic Technologies, Inc. D/B/A Estech | 2009-10-20 | 147 | 0 |
| K091350 | ESTECH HAWKEYE INTRODUCER SYSTEMS | Endoscopic Technologies, Inc. D/B/A Estech | 2009-09-15 | 131 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda