Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ezisurg Medical Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
224 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210909 | easyEndo Lite Linear Cutting Stapler and Loading Unit for Si | Ezisurg Medical Co., Ltd. | 2021-06-24 | 87 | 0 |
| K183477 | easyPPHTM Hemorrhoidal Stapler for Single Use | Ezisurg Medical Co., Ltd. | 2019-02-11 | 56 | 0 |
| K181657 | easyLCTM Linear Cutter Staplers and Loading Units fot Single | Ezisurg Medical Co., Ltd. | 2019-02-01 | 224 | 0 |
| K172960 | easyEndoTM Linear Cutting Stapler and Loading Units for Sing | Ezisurg Medical Co., Ltd. | 2017-12-21 | 86 | 0 |
| K143129 | easyEndo Linear Cutting Stapler and Loading Unit for Single | Ezisurg Medical Co., Ltd. | 2015-01-29 | 90 | 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