Ezisurg Medical Co., Ltd.: FDA clearances and approvals
Ezisurg Medical Co., Ltd. has 5 FDA 510(k) clearances (first 2015, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time: 87 days. Since 2017 its median was 86 days, against 121 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 90 |
| 2016 | 0 | — |
| 2017 | 1 | 86 |
| 2018 | 0 | — |
| 2019 | 2 | 140 |
| 2020 | 0 | — |
| 2021 | 1 | 87 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ezisurg Medical Co., Ltd.'s cleared 510(k)s took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GDW | Staple, Implantable | 5 | 5 |
Review panels
Most recent Ezisurg Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210909 | easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use | GDW | 2021-06-24 | 87 |
| K183477 | easyPPHTM Hemorrhoidal Stapler for Single Use | GDW | 2019-02-11 | 56 |
| K181657 | easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use | GDW | 2019-02-01 | 224 |
| K172960 | easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use | GDW | 2017-12-21 | 86 |
| K143129 | easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) | GDW | 2015-01-29 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Ezisurg Medical Co., Ltd..
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 Ezisurg Medical Co., Ltd. have?
Ezisurg Medical Co., Ltd. has 5 FDA 510(k) clearances (first 2015, latest 2021), across 1 product code in 1 review panel.
How long does FDA take to clear Ezisurg Medical Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Ezisurg Medical Co., Ltd.'s cleared 510(k)s is 87 days. Since 2017: 86 days, versus 121 days for all cleared 510(k)s in the same product codes.
What devices does Ezisurg Medical Co., Ltd. make?
Its most frequent FDA product codes are GDW (Staple, Implantable, 5).
Has Ezisurg Medical Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ezisurg Medical Co., Ltd. Related entities may recall under other names.
Next steps
- See all 5 Ezisurg Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GDW, Ezisurg Medical Co., Ltd.'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.