FDA 510(k)

MFUSE (MS001)

Número K: K250319 · 2025-12-15

Data da decisão2025-12-15

Código do produtoQSY

DecisãoSubstantially Equivalent

Resumo do dispositivo

MFUSE (MS001) is the device name listed in this FDA 510(k) record. The listed applicant is Machina Medical, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K250319. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MFUSE (MS001)?

MFUSE (MS001) is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Machina Medical, Inc.. The 510(k) number is K250319.

When did MFUSE (MS001) receive FDA 510(k) clearance?

MFUSE (MS001) received FDA 510(k) clearance on 2025-12-15, under 510(k) number K250319.

Who is the listed applicant for MFUSE (MS001)?

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

What is the FDA product code for MFUSE (MS001)?

The FDA product code for MFUSE (MS001) is QSY.

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