# Tulavi Therapeutics, Inc.

- Location (FDA's records): Los Gatos, CA
- FDA decisions: 2 (2024–2025): 1 510(k) clearance and 1 De Novo grant
- Names in FDA's records: Tulavi Therapeutics, Inc. (1); Tulavi Therapeutics (1)
- Product codes: SBG (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN230061: allay Nerve Cap (2024), cited by 1

## Recent decisions
- K252051: allay Nerve Cap  (TL5515-1); allay Nerve Cap  (TL5515-2); Delivery Tips (TL-7627) (Sep 29, 2025)
- DEN230061: allay Nerve Cap (Jul 16, 2024)

Source page: https://510kreport.com/company/tulavi-therapeutics