FDA 510(k)

Epione

K-Number: K211645 · 2022-02-24

Decision Date2022-02-24

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Epione is a medical device manufactured by Quantum Surgical Sas. It received FDA 510(k) clearance on 2022-02-24 under approval number K211645. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Epione?

Epione is a medical device that received FDA 510(k) clearance on 2022-02-24. It is manufactured by Quantum Surgical Sas. The 510(k) number is K211645.

When was Epione approved by the FDA?

Epione received FDA 510(k) clearance on 2022-02-24, under approval number K211645.

What company makes Epione?

Epione is manufactured by Quantum Surgical Sas.

What is the FDA product code for Epione?

The FDA product code for Epione is JAK.

Other Devices by Quantum Surgical Sas

K223758Epione

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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.