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FDA 510(k)

Microdacyn Wound Irrigation Solution

K-Number: K261023 · 2026-06-24

ApplicantSonoma Pharmaceuticals, Inc.
Decision Date2026-06-24
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Microdacyn Wound Irrigation Solution 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 2026-06-24 under 510(k) number K261023. 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 Irrigation Solution?

Microdacyn Wound Irrigation Solution is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Sonoma Pharmaceuticals, Inc.. The 510(k) number is K261023.

When did Microdacyn Wound Irrigation Solution receive FDA 510(k) clearance?

Microdacyn Wound Irrigation Solution received FDA 510(k) clearance on 2026-06-24, under 510(k) number K261023.

Who is the listed applicant for Microdacyn Wound Irrigation Solution?

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 Wound Irrigation Solution?

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

Related Clinical Trials

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.

NCT06339203Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)RECRUITINGNCT06439953Irrisept Solution for Instrumented Spine SurgeryRECRUITINGNCT07667036Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative StudyNOT_YET_RECRUITING

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.

K240510Microdacyn HydrogelK233399Microdacyn Wound Care SolutionK173896Microcyn Antimicrobial HydrogelK171935Alevicyn SG Antimicrobial GelK172622Microcyn Antimicrobial Skin and Wound CleanserK172851Microcyn Plus Antimicrobial Wound Care Solution

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Related Devices (Code: FRO)

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.K254191IWD-Gel™InnovaCorium, Inc.

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.

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