FDA 510(k)

Ellian Enigma RF Device

Номер K: K262364 · 2026-09-02

ЗаявительEllian Corp

Дата решения2026-09-02

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.K252535Inno-Switch™ Laparoscopic InstrumentsTaiwan Surgical Corporation

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.