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FDA 510(k)

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

N.º K: K252051 · 2025-09-29

SolicitanteTulavi Therapeutics, Inc.
Fecha de decisión2025-09-29
Código de productoSBG
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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