FDA 510(k)

Microcyn Plus Wound Care Solution

K-Number: K161034 · 2016-08-19

Decision Date2016-08-19

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Microcyn Plus Wound Care Solution is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Innovative Sciences. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K161034. 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 Wound Care Solution?

Microcyn Plus Wound Care Solution is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Oculus Innovative Sciences. The 510(k) number is K161034.

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

Microcyn Plus Wound Care Solution received FDA 510(k) clearance on 2016-08-19, under 510(k) number K161034.

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

The FDA 510(k) record lists Oculus Innovative Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microcyn Plus Wound Care Solution?

The FDA product code for Microcyn Plus Wound Care Solution is FRO. This falls under the Anesthesiology category.

Other records listing Oculus Innovative Sciences 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.

K162217LOYON K153648Microcyn Plus Skin and Wound Hydrogel

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.