FDA 510(k)

Модель P8400 Контроллер для системы Hemostatix Thermal Scalpel C2DX

Номер K: K233185 · 2023-10-24

ЗаявительC2dx, Inc.

Дата решения2023-10-24

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is the device name listed in this FDA 510(k) record. The listed applicant is C2dx, Inc.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K233185. 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 MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is C2dx, Inc.. The 510(k) number is K233185.

When did MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System receive FDA 510(k) clearance?

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K233185.

Who is the listed applicant for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

The FDA 510(k) record lists C2dx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

The FDA product code for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System 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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