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FDA 510(k)

Clyra Wound Irrigation Solution

K-Number: K181428 · 2019-09-20

ApplicantClyra Medical Technologies, Inc.
Decision Date2019-09-20
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Clyra Wound Irrigation Solution is a medical device manufactured by Clyra Medical Technologies, Inc.. It received FDA 510(k) clearance on 2019-09-20 under approval number K181428. 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 Clyra Wound Irrigation Solution?

Clyra Wound Irrigation Solution is a medical device that received FDA 510(k) clearance on 2019-09-20. It is manufactured by Clyra Medical Technologies, Inc.. The 510(k) number is K181428.

When was Clyra Wound Irrigation Solution approved by the FDA?

Clyra Wound Irrigation Solution received FDA 510(k) clearance on 2019-09-20, under approval number K181428.

What company makes Clyra Wound Irrigation Solution?

Clyra Wound Irrigation Solution is manufactured by Clyra Medical Technologies, Inc..

What is the FDA product code for Clyra Wound Irrigation Solution?

The FDA product code for Clyra Wound Irrigation Solution is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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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.

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