Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Protego Antimicrobial Wound Dressing

N.º K: K183681 · 2019-10-11

SolicitanteGlobal Health Solutions (Dba Turn Therapeutics)
Fecha de decisión2019-10-11
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Protego Antimicrobial Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Global Health Solutions (Dba Turn Therapeutics). It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K183681. 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.

Preguntas frecuentes

What is the Protego Antimicrobial Wound Dressing?

Protego Antimicrobial Wound Dressing is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Global Health Solutions (Dba Turn Therapeutics). The 510(k) number is K183681.

When did Protego Antimicrobial Wound Dressing receive FDA 510(k) clearance?

Protego Antimicrobial Wound Dressing received FDA 510(k) clearance on 2019-10-11, under 510(k) number K183681.

Who is the listed applicant for Protego Antimicrobial Wound Dressing?

The FDA 510(k) record lists Global Health Solutions (Dba Turn Therapeutics) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protego Antimicrobial Wound Dressing?

The FDA product code for Protego Antimicrobial Wound Dressing is FRO. This falls under the Anesthesiology category.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: FRO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑