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FDA 510(k)

MFUSE (MS001)

K-Number: K250319 · 2025-12-15

ApplicantMachina Medical, Inc.
Decision Date2025-12-15
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

MFUSE (MS001) is a medical device manufactured by Machina Medical, Inc.. It received FDA 510(k) clearance on 2025-12-15 under approval number K250319. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MFUSE (MS001)?

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

When was MFUSE (MS001) approved by the FDA?

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

What company makes MFUSE (MS001)?

MFUSE (MS001) is manufactured by Machina Medical, Inc..

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

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

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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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