FDA 510(k)

Xonrid Gel

K-Number: K152533 · 2016-10-28

Decision Date2016-10-28

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Xonrid Gel is a medical device manufactured by Helsinn Healthcare SA. It received FDA 510(k) clearance on 2016-10-28 under approval 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.

Frequently Asked Questions

What is the Xonrid Gel?

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

When was Xonrid Gel approved by the FDA?

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

What company makes Xonrid Gel?

Xonrid Gel is manufactured by Helsinn Healthcare SA.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.