Data / Medical devices / South Korea / Dyne Medical Group Inc.
Dyne Medical Group Inc.: FDA-registered device maker in Gimpo- si Gyeonggi, South Korea, 2 510(k) clearances
Dyne Medical Group Inc. is registered with the FDA (registration 3032578846) in Gimpo- si Gyeonggi, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 12, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3032578846
- Address
- #1001-1013, #1015-1016, #1024-1025, 10F, 165, Gimpohangang 10-ro 133beon-gil, Gimpo- si Gyeonggi, South Korea, 10071
- Owner or operator
- DYNE Medical Group Inc. (10091398)
- Roles
- Manufacturer
- First device listed
- September 20, 2024
- Registered through
- 2026
- Brand names listed
- DYNE PORT, URUS, URUS System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscope Channel Accessory | ODC | 2 | Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 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 |
|---|---|---|---|---|---|---|
| June 12, 2026 | K252933 | DYNE PORT | ODC | Substantially Equivalent | Dyne Medical Group, Inc. | accessdata.fda.gov |
| September 5, 2024 | K240203 | URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) | FGB | Substantially Equivalent | Dyne Medical Group, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 12, 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.