FDA applicant
Tulavi Therapeutics, Inc.
FDA records 2 decisions for Tulavi Therapeutics, Inc. (Los Gatos, CA) from 2024 to 2025: 1 510(k) clearance and 1 De Novo grant. All are in product code SBG (In Situ Polymerizing Peripheral Nerve Cap). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Tulavi Therapeutics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tulavi Therapeutics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Tulavi Therapeutics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report