Data / Medical devices / Taiwan / Clearmind Biomedical
Clearmind Biomedical: FDA-registered device maker in Taipei City, Taiwan, 2 510(k) clearances
Clearmind Biomedical is registered with the FDA (registration 3015449142) in Taipei City, Taiwan. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 13, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015449142
- Address
- 5F, No. 167, Fuxing N. Rd., Songshan Dist. Taipei City, Taiwan (R.O.C.), Taipei City, Taiwan, 105403
- Owner or operator
- CLEARMIND BIOMEDICAL (10082062)
- Roles
- Exporter to the US, Specification developer
- First device listed
- June 11, 2021
- Registered through
- 2027
- Brand names listed
- ClearPath Disposable Introducer, Neuroblade System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Endoscope, Neurological | GWG | 2 | Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 13, 2023 | K230125 | Neuroblade System | GWG | Substantially Equivalent | Clearmind Biomedical | accessdata.fda.gov |
| April 2, 2021 | K210251 | ClearPath Disposable Introducer | GWG | Substantially Equivalent | Clearmind Biomedical | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscope, Neurological
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated October 13, 2023. 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.