Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)

K-Number: K252051 · 2025-09-29

ApplicantTulavi Therapeutics, Inc.
Decision Date2025-09-29
Product CodeSBG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) is the device name listed in this FDA 510(k) record. The listed applicant is Tulavi Therapeutics, Inc.. It received FDA 510(k) clearance on 2025-09-29 under 510(k) number K252051. The device is classified under product code SBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)?

allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Tulavi Therapeutics, Inc.. The 510(k) number is K252051.

When did allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) receive FDA 510(k) clearance?

allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) received FDA 510(k) clearance on 2025-09-29, under 510(k) number K252051.

Who is the listed applicant for allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)?

The FDA 510(k) record lists Tulavi Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)?

The FDA product code for allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) is SBG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07246980Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success StudyRECRUITING

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑