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FDA 510(k)

Epione

K-Number: K223758 · 2023-05-03

ApplicantQuantum Surgical Sas
Decision Date2023-05-03
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 2023-05-03 under approval number K223758. 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 2023-05-03. It is manufactured by Quantum Surgical Sas. The 510(k) number is K223758.

When was Epione approved by the FDA?

Epione received FDA 510(k) clearance on 2023-05-03, under approval number K223758.

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

K211645Epione

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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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