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FDA 510(k)

Elucis

K-Number: K220649 · 2023-01-17

ApplicantRealize Medical, Inc.
Decision Date2023-01-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Elucis is a medical device manufactured by Realize Medical, Inc.. It received FDA 510(k) clearance on 2023-01-17 under approval number K220649. 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 Elucis?

Elucis is a medical device that received FDA 510(k) clearance on 2023-01-17. It is manufactured by Realize Medical, Inc.. The 510(k) number is K220649.

When was Elucis approved by the FDA?

Elucis received FDA 510(k) clearance on 2023-01-17, under approval number K220649.

What company makes Elucis?

Elucis is manufactured by Realize Medical, Inc..

What is the FDA product code for Elucis?

The FDA product code for Elucis is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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