FDA 510(k)

Boston PICO (Boston PICO)

Número K: K251981 · 2026-01-30

Data da decisão2026-01-30

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Boston PICO (Boston PICO) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K251981. 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.

Perguntas frequentes

What is the Boston PICO (Boston PICO)?

Boston PICO (Boston PICO) is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Boston Aesthetics, Inc.. The 510(k) number is K251981.

When did Boston PICO (Boston PICO) receive FDA 510(k) clearance?

Boston PICO (Boston PICO) received FDA 510(k) clearance on 2026-01-30, under 510(k) number K251981.

Who is the listed applicant for Boston PICO (Boston PICO)?

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

What is the FDA product code for Boston PICO (Boston PICO)?

The FDA product code for Boston PICO (Boston PICO) is GEX. This falls under the Gastroenterology category.

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Outros registros que listam Boston Aesthetics, Inc. como candidato(a)

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