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FDA 510(k)

Esteya

K-Number: K213942 · 2022-01-11

ApplicantNucletron B.V.
Decision Date2022-01-11
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Esteya is a medical device manufactured by Nucletron B.V.. It received FDA 510(k) clearance on 2022-01-11 under approval number K213942. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Esteya?

Esteya is a medical device that received FDA 510(k) clearance on 2022-01-11. It is manufactured by Nucletron B.V.. The 510(k) number is K213942.

When was Esteya approved by the FDA?

Esteya received FDA 510(k) clearance on 2022-01-11, under approval number K213942.

What company makes Esteya?

Esteya is manufactured by Nucletron B.V..

What is the FDA product code for Esteya?

The FDA product code for Esteya is JAD.

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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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