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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 a medical device manufactured by Tulavi Therapeutics, Inc.. It received FDA 510(k) clearance on 2025-09-29 under approval 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. It is manufactured by Tulavi Therapeutics, Inc.. The 510(k) number is K252051.

When was allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) approved by the FDA?

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

What company makes 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 manufactured by Tulavi Therapeutics, Inc..

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

NCT05110183 Opto-electrical Cochlear Implants ENROLLING_BY_INVITATION NCT06915662 Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap RECRUITING NCT07095946 Effectiveness of Intraligament vs IANB Anesthesia in Children Using Electronic Syringe RECRUITING

Related Devices (Code: SBG)

DEN230061allay Nerve CapTulavi Therapeutics

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.

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