Data / Medical devices / South Korea / Koh Young Technology Inc.
Koh Young Technology Inc.: FDA-registered device maker in Yeoju Gyeonggi, South Korea, 2 510(k) clearances
Koh Young Technology Inc. is registered with the FDA (registration 3027375826) in Yeoju Gyeonggi, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 10, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027375826
- Address
- 1F, 66-27, Gwangdae 2-gil Sejongdaewang-myeon, Yeoju Gyeonggi, South Korea, 12647
- Owner or operator
- KOH YOUNG TECHNOLOGY INC. (10092592)
- Roles
- Manufacturer
- First device listed
- January 24, 2025
- Registered through
- 2027
- Brand names listed
- Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 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 10, 2026 | K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | HAW | Substantially Equivalent | Koh Young Technology, Inc. | accessdata.fda.gov |
| January 17, 2025 | K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | HAW | Substantially Equivalent | Koh Young Technology, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 10, 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.