FDA 510(k)

Curativo Cirúrgico ACTICOAT

Número K: K153723 · 2016-09-14

RequerenteSmith & Nephew Medical Limited

Data da decisão2016-09-14

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ACTICOAT Surgical Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K153723. 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 ACTICOAT Surgical Dressing?

ACTICOAT Surgical Dressing is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K153723.

When did ACTICOAT Surgical Dressing receive FDA 510(k) clearance?

ACTICOAT Surgical Dressing received FDA 510(k) clearance on 2016-09-14, under 510(k) number K153723.

Who is the listed applicant for ACTICOAT Surgical Dressing?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTICOAT Surgical Dressing?

The FDA product code for ACTICOAT Surgical Dressing 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 Smith & Nephew Medical Limited como candidato(a)

K242146BIOBRANE Temporary Wound Dressing; BIOBRANE Glove K223526Allevyn Ag+ Adesivo de Gel Antimicrobiano de Silicone na Borda, Allevyn Ag+ Adesivo de Gel Antimicrobiano de Silicone Sacro, Allevyn Ag+ Adesivo de Gel Antimicrobiano de Silicone Cirúrgico K220964VERSAJET Hydrosurgery System (III)K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large K223041Renasys Edge (66803126)K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing

Ver todos os 21 dispositivos →

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.