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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K262364

510(k) cleared

Ellian Enigma RF Device

Ellian Corp · Sep 2, 2026 · K262364

FDA cleared the Ellian Enigma RF Device from Ellian Corp on Sep 2, 2026 under K262364, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 10, 2026. The decision came 54 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ellian Corp in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262364?

K262364 is the FDA 510(k) for Ellian Enigma RF Device, submitted by Ellian Corp. FDA's decision date was Sep 2, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Ellian Enigma RF Device?

Ellian Corp, based in Plano, TX, is the applicant of record for K262364.

How long did the K262364 review take?

FDA received the submission on Jul 10, 2026 and issued its decision on Sep 2, 2026, 54 days later.

← All decisions in September 2026