FDA 510(k)

Ross Ru Wound Dressing Gel

Номер K: K162017 · 2017-04-20

ЗаявительBiotd S.A.

Дата решения2017-04-20

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

Ross Ru Wound Dressing Gel is the device name listed in this FDA 510(k) record. The listed applicant is Biotd S.A.. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K162017. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Ross Ru Wound Dressing Gel?

Ross Ru Wound Dressing Gel is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Biotd S.A.. The 510(k) number is K162017.

When did Ross Ru Wound Dressing Gel receive FDA 510(k) clearance?

Ross Ru Wound Dressing Gel received FDA 510(k) clearance on 2017-04-20, under 510(k) number K162017.

Who is the listed applicant for Ross Ru Wound Dressing Gel?

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

What is the FDA product code for Ross Ru Wound Dressing Gel?

The FDA product code for Ross Ru Wound Dressing Gel is FRO. This falls under the Anesthesiology category.

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: FRO)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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.