Data / Medical devices / South Korea / Hyundae Meditech Co., Ltd.
Hyundae Meditech Co., Ltd.: FDA-registered device maker in Wonju Gangwon, South Korea, 2 510(k) clearances
Hyundae Meditech Co., Ltd. is registered with the FDA (registration 3015812758) in Wonju Gangwon, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 27, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015812758
- Address
- 80, Cheongjeong-ro, Jijeong-myeon, Wonju Gangwon, South Korea, 26347
- Owner or operator
- Hyundae Meditech Co., Ltd. (10080349)
- Roles
- Manufacturer
- First device listed
- March 29, 2024
- Registered through
- 2027
- Brand names listed
- i-Thread
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 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 27, 2024 | K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 | NEW | Substantially Equivalent | Hyundae Meditech Co., Ltd. | accessdata.fda.gov |
| March 27, 2024 | K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) | NEW | Substantially Equivalent | Hyundae Meditech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 27, 2024. 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.