FDA 510(k)

DUET-V (Model: ESK-3261DV)

Номер K: K233118 · 2025-01-03

Дата решения2025-01-03

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

DUET-V (Model: ESK-3261DV) is the device name listed in this FDA 510(k) record. The listed applicant is Eunsung Global Corp. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K233118. 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 DUET-V (Model: ESK-3261DV)?

DUET-V (Model: ESK-3261DV) is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Eunsung Global Corp. The 510(k) number is K233118.

When did DUET-V (Model: ESK-3261DV) receive FDA 510(k) clearance?

DUET-V (Model: ESK-3261DV) received FDA 510(k) clearance on 2025-01-03, under 510(k) number K233118.

Who is the listed applicant for DUET-V (Model: ESK-3261DV)?

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

What is the FDA product code for DUET-V (Model: ESK-3261DV)?

The FDA product code for DUET-V (Model: ESK-3261DV) 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.

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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 K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Официальный источник

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