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FDA 510(k)

Libby IAAA v1.0

K-Number: K210931 · 2021-12-17

ApplicantDyad Medical, Inc.
Decision Date2021-12-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Libby IAAA v1.0 is a medical device manufactured by Dyad Medical, Inc.. It received FDA 510(k) clearance on 2021-12-17 under approval number K210931. 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 Libby IAAA v1.0?

Libby IAAA v1.0 is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Dyad Medical, Inc.. The 510(k) number is K210931.

When was Libby IAAA v1.0 approved by the FDA?

Libby IAAA v1.0 received FDA 510(k) clearance on 2021-12-17, under approval number K210931.

What company makes Libby IAAA v1.0?

Libby IAAA v1.0 is manufactured by Dyad Medical, Inc..

What is the FDA product code for Libby IAAA v1.0?

The FDA product code for Libby IAAA v1.0 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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