FDA 510(k)

DEX Device

Номер K: K191878 · 2021-01-29

ЗаявительDex Surgical

Дата решения2021-01-29

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

DEX Device is the device name listed in this FDA 510(k) record. The listed applicant is Dex Surgical. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K191878. 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 DEX Device?

DEX Device is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Dex Surgical. The 510(k) number is K191878.

When did DEX Device receive FDA 510(k) clearance?

DEX Device received FDA 510(k) clearance on 2021-01-29, under 510(k) number K191878.

Who is the listed applicant for DEX Device?

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

What is the FDA product code for DEX Device?

The FDA product code for DEX 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 K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Официальный источник

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