Data / Medical devices / United States / Brain Navi LLC
Brain Navi LLC: FDA-registered device maker in Wilmington, DE, United States, 1 510(k) clearance
Brain Navi LLC is registered with the FDA (registration 3042048690) in Wilmington, DE, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3042048690
- Address
- 919 N Market St Ste 950, Wilmington, DE, United States, 19801
- Owner or operator
- Brain Navi LLC (10094347)
- Roles
- Complaint file establishment
- First device listed
- November 26, 2025
- Registered through
- 2027
- Brand names listed
- NaoTrac S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| May 23, 2025 | K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | HAW | Substantially Equivalent | Brain Navi Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 23, 2025. 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.