FDA 510(k)

Monopolar Electrode Surgical Instrument

Номер K: K230650 · 2023-10-12

Дата решения2023-10-12

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Monopolar Electrode Surgical Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Vhmed (Nantong) Co. , Ltd.. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K230650. 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 Monopolar Electrode Surgical Instrument?

Monopolar Electrode Surgical Instrument is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Vhmed (Nantong) Co. , Ltd.. The 510(k) number is K230650.

When did Monopolar Electrode Surgical Instrument receive FDA 510(k) clearance?

Monopolar Electrode Surgical Instrument received FDA 510(k) clearance on 2023-10-12, under 510(k) number K230650.

Who is the listed applicant for Monopolar Electrode Surgical Instrument?

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

What is the FDA product code for Monopolar Electrode Surgical Instrument?

The FDA product code for Monopolar Electrode Surgical Instrument 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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