Data / Medical devices / United States / Tulavi Therapeutics
Tulavi Therapeutics: FDA-registered device maker in Los Gatos, CA, United States, 2 510(k) clearances
Tulavi Therapeutics is registered with the FDA (registration 3027562169) in Los Gatos, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027562169
- Address
- 160 Knowles Dr, Los Gatos, CA, United States, 95032
- Owner or operator
- Tulavi Therapeutics (10091184)
- Roles
- Manufacturer
- First device listed
- July 18, 2024
- Registered through
- 2026
- Brand names listed
- Delivery Tip, allay Nerve Cap - Large Nerve Set, allay Nerve Cap - Small Nerve Set, allay Nerve Cap Large Nerve, allay Nerve Cap Small Nerve
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| In Situ Polymerizing Peripheral Nerve Cap | SBG | 2 | 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 |
|---|---|---|---|---|---|---|
| September 29, 2025 | K252051 | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | SBG | Substantially Equivalent | Tulavi Therapeutics, Inc. | accessdata.fda.gov |
| July 16, 2024 | DEN230061 | allay Nerve Cap | SBG | Unknown | Tulavi Therapeutics | accessdata.fda.gov |
Updated September 29, 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.