FDA 510(k)

E-Brik Visualization Assistant

Номер K: K221293 · 2022-07-07

Дата решения2022-07-07

Код продуктаOCT

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

E-Brik Visualization Assistant is the device name listed in this FDA 510(k) record. The listed applicant is Jdi Surgical, Inc.. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K221293. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the E-Brik Visualization Assistant?

E-Brik Visualization Assistant is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Jdi Surgical, Inc.. The 510(k) number is K221293.

When did E-Brik Visualization Assistant receive FDA 510(k) clearance?

E-Brik Visualization Assistant received FDA 510(k) clearance on 2022-07-07, under 510(k) number K221293.

Who is the listed applicant for E-Brik Visualization Assistant?

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

What is the FDA product code for E-Brik Visualization Assistant?

The FDA product code for E-Brik Visualization Assistant is OCT.

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: OCT)

K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.K231822GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc.K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd.K163257VitreOx Anti-fog SolutionSio2 Nanotech, LLC K152948Medline Anti-Fog SolutionMedline Industries, Inc.

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.