Microdacyn Hydrogel
K-Number: K240510 · 2024-11-08
ApplicantSonoma Pharmaceuticals, Inc.
Decision Date2024-11-08
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Microdacyn Hydrogel is a medical device manufactured by Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2024-11-08 under approval number K240510. 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 Hydrogel?
Microdacyn Hydrogel is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by Sonoma Pharmaceuticals, Inc.. The 510(k) number is K240510.
When was Microdacyn Hydrogel approved by the FDA?
Microdacyn Hydrogel received FDA 510(k) clearance on 2024-11-08, under approval number K240510.
What company makes Microdacyn Hydrogel?
Microdacyn Hydrogel is manufactured by Sonoma Pharmaceuticals, Inc..
What is the FDA product code for Microdacyn Hydrogel?
The FDA product code for Microdacyn Hydrogel is FRO. This falls under the Anesthesiology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.