Data / Medical devices / United States / Borvo Medical, Inc.
Borvo Medical, Inc.: FDA-registered device maker in Mountain View, CA, United States, 1 510(k) clearance
Borvo Medical, Inc. is registered with the FDA (registration 3033728927) in Mountain View, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 20, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3033728927
- Address
- 2500 Old Middlefield Way Ste E, Mountain View, CA, United States, 94043
- Owner or operator
- Borvo Medical, Inc. (10091963)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 20, 2024
- Registered through
- 2027
- Brand names listed
- Borvo EVAC, Tube Clearing Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Shunt, Central Nervous System And Components | JXG | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 20, 2024 | K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | JXG | Substantially Equivalent | Borvo Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Shunt, Central Nervous System And Components
- All makers of Clamp, Surgical, General & Plastic Surgery
Updated August 20, 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.