FDA 510(k)

Dermatrix Duo

Номер K: K251836 · 2026-02-06

ЗаявительShenzhen Gsd Technology Co., Ltd.

Дата решения2026-02-06

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Dermatrix Duo is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Gsd Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K251836. 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 Dermatrix Duo?

Dermatrix Duo is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Shenzhen Gsd Technology Co., Ltd.. The 510(k) number is K251836.

When did Dermatrix Duo receive FDA 510(k) clearance?

Dermatrix Duo received FDA 510(k) clearance on 2026-02-06, under 510(k) number K251836.

Who is the listed applicant for Dermatrix Duo?

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

What is the FDA product code for Dermatrix Duo?

The FDA product code for Dermatrix Duo 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

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.