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FDA 510(k)

IWD-Gel™

N.º K: K254191 · 2026-04-07

SolicitanteInnovaCorium, Inc.
Fecha de decisión2026-04-07
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

IWD-Gel™ is the device name listed in this FDA 510(k) record. The listed applicant is InnovaCorium, Inc.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K254191. 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 IWD-Gel™?

IWD-Gel™ is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is InnovaCorium, Inc.. The 510(k) number is K254191.

When did IWD-Gel™ receive FDA 510(k) clearance?

IWD-Gel™ received FDA 510(k) clearance on 2026-04-07, under 510(k) number K254191.

Who is the listed applicant for IWD-Gel™?

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

What is the FDA product code for IWD-Gel™?

The FDA product code for IWD-Gel™ is FRO. This falls under the Anesthesiology category.

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.

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