Data / Medical devices / China / Ezisurg Medical Co., Ltd.
Ezisurg Medical Co., Ltd.: FDA-registered device maker in Shanghai, China, 5 510(k) clearances
Ezisurg Medical Co., Ltd. is registered with the FDA (registration 3014264910) in Shanghai, China. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 25, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014264910
- Address
- No. 399, Miaoqiao Rd., Pudong New District, Shanghai, China, 201315
- Owner or operator
- Ezisurg Medical Co., Ltd. (10056707)
- Roles
- Manufacturer
- First device listed
- January 8, 2018
- Registered through
- 2026
- Brand names listed
- easyCS Circular Stapler for Single Use (CS2135, CS2148, CS2535, CS2548, CS2935, CS2948, CS3148, CS3348), easyEndo Flex Loading Unit (R30W, R30B, R45W, R45B, R45C, R45G, R60W, R60B, R60C, R60G), easyEndo Linear Cutting Stapler for Single Use (F12S, F12M, F12L), easyEndo Lite Linear Cutting Stapler for Single Use (U12S45, U12S60, U12M45, U12M60, U12L45, U12L60), easyEndo Lite Loading Units for Single Use (N45M, N45W, N45B, N45C, N45G, N60M, N60W, N60B, N60C, N60G), easyEndo Loading Units for Single Use (FDU45W, FDU45B, FDU45G, FDU60B, FDU60G), easyEndo Pro Loading Unit (L30W, L30B, L45W, L45B, L45C, L45G, L60W, L60B, L60C, L60G), easyEndo Universal Linear Cutting Stapler (U12S, U12M, U12L) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Staple, Implantable | GDW | 2 | Manufacturer | accessdata.fda.gov |
| Stapler, Surgical | GAG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | K254291 | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges | GDW | Substantially Equivalent | Ezisurg Medical Co., Ltd. | accessdata.fda.gov |
| June 24, 2021 | K210909 | easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use | GDW | Substantially Equivalent | Ezisurg Medical Co., Ltd. | accessdata.fda.gov |
| February 1, 2019 | K181657 | easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use | GDW | Substantially Equivalent | Ezisurg Medical Co., Ltd. | accessdata.fda.gov |
| December 21, 2017 | K172960 | easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use | GDW | Substantially Equivalent | Ezisurg Medical Co., Ltd. | accessdata.fda.gov |
| January 29, 2015 | K143129 | easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) | GDW | Substantially Equivalent | Ezisurg Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.