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FDA 510(k)

Mosaic (V1.0.1)

K-Number: K244012 · 2025-06-16

ApplicantNavier Medical
Decision Date2025-06-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mosaic (V1.0.1) is a medical device manufactured by Navier Medical. It received FDA 510(k) clearance on 2025-06-16 under approval number K244012. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mosaic (V1.0.1)?

Mosaic (V1.0.1) is a medical device that received FDA 510(k) clearance on 2025-06-16. It is manufactured by Navier Medical. The 510(k) number is K244012.

When was Mosaic (V1.0.1) approved by the FDA?

Mosaic (V1.0.1) received FDA 510(k) clearance on 2025-06-16, under approval number K244012.

What company makes Mosaic (V1.0.1)?

Mosaic (V1.0.1) is manufactured by Navier Medical.

What is the FDA product code for Mosaic (V1.0.1)?

The FDA product code for Mosaic (V1.0.1) is LLZ.

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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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