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)

G4Derm / G4Derm Plus Synthetic Wound Matrix

N.º K: K222025 · 2023-10-11

SolicitanteGel4med, Inc.
Fecha de decisión2023-10-11
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

G4Derm / G4Derm Plus Synthetic Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Gel4med, Inc.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K222025. 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 G4Derm / G4Derm Plus Synthetic Wound Matrix?

G4Derm / G4Derm Plus Synthetic Wound Matrix is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Gel4med, Inc.. The 510(k) number is K222025.

When did G4Derm / G4Derm Plus Synthetic Wound Matrix receive FDA 510(k) clearance?

G4Derm / G4Derm Plus Synthetic Wound Matrix received FDA 510(k) clearance on 2023-10-11, under 510(k) number K222025.

Who is the listed applicant for G4Derm / G4Derm Plus Synthetic Wound Matrix?

The FDA 510(k) record lists Gel4med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G4Derm / G4Derm Plus Synthetic Wound Matrix?

The FDA product code for G4Derm / G4Derm Plus Synthetic Wound Matrix 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.

↑