Data / Medical devices / South Korea / Nextbiomedical Co., Ltd
Nextbiomedical Co., Ltd: FDA-registered device maker in Incheon, South Korea, 2 510(k) clearances
Nextbiomedical Co., Ltd is registered with the FDA (registration 3020614064) in Incheon, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020614064
- Address
- 6, Venture-ro 100beon-gil, Yeonsu-gu, Incheon, South Korea, 22013
- Owner or operator
- NEXTBIOMEDICAL CO., LTD (10084721)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 19, 2022
- Registered through
- 2027
- Brand names listed
- Nexpowder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Device For Endoscopic Gastrointestinal Use | QAU | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| November 27, 2024 | K240994 | Nexpowder | QAU | Substantially Equivalent | Nextbiomedical Co., Ltd. | accessdata.fda.gov |
| September 16, 2022 | K202929 | Nexpowder | QAU | Substantially Equivalent | Nextbiomedical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 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.