FDA 510(k)

Microdacyn Hydrogel

K-Number: K240510 · 2024-11-08

Decision Date2024-11-08

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Microdacyn Hydrogel is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) 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. The listed applicant is Sonoma Pharmaceuticals, Inc.. The 510(k) number is K240510.

When did Microdacyn Hydrogel receive FDA 510(k) clearance?

Microdacyn Hydrogel received FDA 510(k) clearance on 2024-11-08, under 510(k) number K240510.

Who is the listed applicant for Microdacyn Hydrogel?

The FDA 510(k) record lists Sonoma Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microdacyn Hydrogel?

The FDA product code for Microdacyn Hydrogel is FRO. This falls under the Anesthesiology category.

Other records listing Sonoma Pharmaceuticals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.