allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)— 510(k) K252051

Name: FDA 510(k) clearance K252051
Creator: U.S. Food and Drug Administration
Published: 2025-09-29

Substantially Equivalent

Tulavi Therapeutics, Inc.

FDA 510(k) clearance K252051 for allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627), Substantially Equivalent on 2025-09-29. Applicant: Tulavi Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Tulavi Therapeutics, Inc.
Product code: Code SBG
Device class: Class 2
Regulation: 21 CFR 882.5260
Advisory panel: Neurology
Date received: 2025-07-01
Decision date: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Gatos, CA, US

Download summary PDF View on FDA.gov ↗

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