FDA 510(k)

Epione

K-Number: K211645 · 2022-02-24

Decision Date2022-02-24

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Epione is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Surgical Sas. It received FDA 510(k) clearance on 2022-02-24 under 510(k) 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. The listed applicant is Quantum Surgical Sas. The 510(k) number is K211645.

When did Epione receive FDA 510(k) clearance?

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

Who is the listed applicant for Epione?

The FDA 510(k) record lists Quantum Surgical Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Epione?

The FDA product code for Epione is JAK.

Other records listing Quantum Surgical Sas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.