Data / Medical devices / United States / Gravitas Medical, Inc.
Gravitas Medical, Inc.: FDA-registered device maker in Berkeley, CA, United States, 1 510(k) clearance
Gravitas Medical, Inc. is registered with the FDA (registration 3034881464) in Berkeley, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034881464
- Address
- 2332 4th St Ste E, Berkeley, CA, United States, 94710
- Owner or operator
- Gravitas Medical, Inc. (10096287)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 21, 2026
- Registered through
- 2026
- Brand names listed
- Entarik G2 Monitor, Entarik G2 NI Feeding Tube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tube, Feeding | FPD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 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 22, 2024 | K241169 | Entarik NI Feeding Tube System | KNT | Substantially Equivalent | Gravitas Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 22, 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.