FDA 510(k)

Microcyn Plus Antimicrobial Wound Care Solution

K-Number: K172851 · 2017-11-15

Decision Date2017-11-15

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Microcyn Plus Antimicrobial Wound Care 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 2017-11-15 under 510(k) number K172851. 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 Microcyn Plus Antimicrobial Wound Care Solution?

Microcyn Plus Antimicrobial Wound Care Solution is a medical device that received FDA 510(k) clearance on 2017-11-15. The listed applicant is Sonoma Pharmaceuticals, Inc.. The 510(k) number is K172851.

When did Microcyn Plus Antimicrobial Wound Care Solution receive FDA 510(k) clearance?

Microcyn Plus Antimicrobial Wound Care Solution received FDA 510(k) clearance on 2017-11-15, under 510(k) number K172851.

Who is the listed applicant for Microcyn Plus Antimicrobial Wound Care 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 Microcyn Plus Antimicrobial Wound Care Solution?

The FDA product code for Microcyn Plus Antimicrobial Wound Care Solution 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.

K261023Microdacyn Wound Irrigation Solution K240510Microdacyn Hydrogel K233399Microdacyn Wound Care Solution K173896Microcyn Antimicrobial Hydrogel K171935Alevicyn SG Antimicrobial Gel K172622Microcyn Antimicrobial Skin and Wound Cleanser

View all 8 devices →

Related Devices (Code: FRO)

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, 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.