FDA 510(k)

Microdacyn Wound Care Solution

K-Number: K233399 · 2024-09-13

Decision Date2024-09-13

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Microdacyn Wound Care Solution is a medical device manufactured by Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2024-09-13 under approval number K233399. 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 Microdacyn Wound Care Solution?

Microdacyn Wound Care Solution is a medical device that received FDA 510(k) clearance on 2024-09-13. It is manufactured by Sonoma Pharmaceuticals, Inc.. The 510(k) number is K233399.

When was Microdacyn Wound Care Solution approved by the FDA?

Microdacyn Wound Care Solution received FDA 510(k) clearance on 2024-09-13, under approval number K233399.

What company makes Microdacyn Wound Care Solution?

Microdacyn Wound Care Solution is manufactured by Sonoma Pharmaceuticals, Inc..

What is the FDA product code for Microdacyn Wound Care Solution?

The FDA product code for Microdacyn Wound Care 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.