Data / Medical devices / South Korea / Saeyang Co., Ltd.
Saeyang Co., Ltd.: FDA-registered device maker in DALSEO-GU Daegu, South Korea, 4 510(k) clearances
Saeyang Co., Ltd. is registered with the FDA (registration 3010551934) in DALSEO-GU Daegu, South Korea. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 19, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010551934
- Address
- (Galsan-Dong), 348 SEONGSEO-RO, DALSEO-GU Daegu, South Korea, 42697
- Owner or operator
- SAEYANG CO., LTD. (10086948)
- Roles
- Manufacturer
- First device listed
- December 26, 2022
- Registered through
- 2026
- Brand names listed
- CanalPro CL2, Endo A Class, Endo E Class, Ki-20, PRO M CLASS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Controller, Foot, Handpiece And Cord | EBW | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | 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 19, 2022 | K213897 | Pro M Class | EKX | Substantially Equivalent | Saeyang Microtech Co., Ltd. | accessdata.fda.gov |
| April 24, 2015 | K141482 | KI-20 | EBW | Substantially Equivalent | Saeyang Microtech Co., Ltd. | accessdata.fda.gov |
| August 16, 2013 | K123608 | ENDO E CLASS | EBW | Substantially Equivalent | Saeyang Microtech Co., Ltd. | accessdata.fda.gov |
| August 16, 2013 | K123582 | ENDO A CLASS | EKX | Substantially Equivalent | Saeyang Microtech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 19, 2022. 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.