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FDA 510(k)

The Botticelli (Model: Athena)

N.º K: K251699 · 2025-10-08

SolicitanteBellamia Technologies, Inc.
Fecha de decisión2025-10-08
Código de productoGEX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

The Botticelli (Model: Athena) is the device name listed in this FDA 510(k) record. The listed applicant is Bellamia Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K251699. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the The Botticelli (Model: Athena)?

The Botticelli (Model: Athena) is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Bellamia Technologies, Inc.. The 510(k) number is K251699.

When did The Botticelli (Model: Athena) receive FDA 510(k) clearance?

The Botticelli (Model: Athena) received FDA 510(k) clearance on 2025-10-08, under 510(k) number K251699.

Who is the listed applicant for The Botticelli (Model: Athena)?

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

What is the FDA product code for The Botticelli (Model: Athena)?

The FDA product code for The Botticelli (Model: Athena) is GEX. This falls under the Gastroenterology category.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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