FDA 510(k)

Xonrid Gel

N.º K: K152533 · 2016-10-28

Fecha de decisión2016-10-28

Código de productoFRO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Xonrid Gel is the device name listed in this FDA 510(k) record. The listed applicant is Helsinn Healthcare SA. It received FDA 510(k) clearance on 2016-10-28 under 510(k) number K152533. 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 Xonrid Gel?

Xonrid Gel is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is Helsinn Healthcare SA. The 510(k) number is K152533.

When did Xonrid Gel receive FDA 510(k) clearance?

Xonrid Gel received FDA 510(k) clearance on 2016-10-28, under 510(k) number K152533.

Who is the listed applicant for Xonrid Gel?

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

What is the FDA product code for Xonrid Gel?

The FDA product code for Xonrid Gel is FRO. This falls under the Anesthesiology category.

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Fuente oficial

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