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FDA 510(k)

Ellian Enigma RF Device

K-Number: K262364 · 2026-09-02

ApplicantEllian Corp
Decision Date2026-09-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ellian Enigma RF Device is the device name listed in this FDA 510(k) record. The listed applicant is Ellian Corp. It received FDA 510(k) clearance on 2026-09-02 under 510(k) number K262364. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ellian Enigma RF Device?

Ellian Enigma RF Device is a medical device that received FDA 510(k) clearance on 2026-09-02. The listed applicant is Ellian Corp. The 510(k) number is K262364.

When did Ellian Enigma RF Device receive FDA 510(k) clearance?

Ellian Enigma RF Device received FDA 510(k) clearance on 2026-09-02, under 510(k) number K262364.

Who is the listed applicant for Ellian Enigma RF Device?

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

What is the FDA product code for Ellian Enigma RF Device?

The FDA product code for Ellian Enigma RF Device is GEI.

Related Devices (Code: GEI)

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.

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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.

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