FDA 510(k)

Hydrocleanse Antimicrobial Skin and Wound Care Solution

Número K: K171727 · 2017-07-26

Data da decisão2017-07-26

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hydrocleanse Antimicrobial Skin and Wound Care Solution is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals. It received FDA 510(k) clearance on 2017-07-26 under 510(k) number K171727. 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.

Perguntas frequentes

What is the Hydrocleanse Antimicrobial Skin and Wound Care Solution?

Hydrocleanse Antimicrobial Skin and Wound Care Solution is a medical device that received FDA 510(k) clearance on 2017-07-26. The listed applicant is Sonoma Pharmaceuticals. The 510(k) number is K171727.

When did Hydrocleanse Antimicrobial Skin and Wound Care Solution receive FDA 510(k) clearance?

Hydrocleanse Antimicrobial Skin and Wound Care Solution received FDA 510(k) clearance on 2017-07-26, under 510(k) number K171727.

Who is the listed applicant for Hydrocleanse Antimicrobial Skin and Wound Care Solution?

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

What is the FDA product code for Hydrocleanse Antimicrobial Skin and Wound Care Solution?

The FDA product code for Hydrocleanse Antimicrobial Skin and Wound Care Solution is FRO. This falls under the Anesthesiology category.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Sonoma Pharmaceuticals como candidato(a)

K172622Microcyn Antimicrobial Skin and Wound Cleanser

Dispositivos Relacionados (Código: 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.