FDA 510(k)

Coolfase

Номер K: K250852 · 2025-10-16

Дата решения2025-10-16

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Coolfase is the device name listed in this FDA 510(k) record. The listed applicant is Asterasys Co., Ltd.. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K250852. 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 Coolfase?

Coolfase is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Asterasys Co., Ltd.. The 510(k) number is K250852.

When did Coolfase receive FDA 510(k) clearance?

Coolfase received FDA 510(k) clearance on 2025-10-16, under 510(k) number K250852.

Who is the listed applicant for Coolfase?

The FDA 510(k) record lists Asterasys Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coolfase?

The FDA product code for Coolfase 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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