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FDA 510(k)

OCULUS MICROCYN WOUND GEL

K-Number: K090725 · 2009-05-20

ApplicantOculus Innovative Sciences, Inc.
Decision Date2009-05-20
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

OCULUS MICROCYN WOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Innovative Sciences, Inc.. It received FDA 510(k) clearance on 2009-05-20 under 510(k) number K090725. 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 OCULUS MICROCYN WOUND GEL?

OCULUS MICROCYN WOUND GEL is a medical device that received FDA 510(k) clearance on 2009-05-20. The listed applicant is Oculus Innovative Sciences, Inc.. The 510(k) number is K090725.

When did OCULUS MICROCYN WOUND GEL receive FDA 510(k) clearance?

OCULUS MICROCYN WOUND GEL received FDA 510(k) clearance on 2009-05-20, under 510(k) number K090725.

Who is the listed applicant for OCULUS MICROCYN WOUND GEL?

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

What is the FDA product code for OCULUS MICROCYN WOUND GEL?

The FDA product code for OCULUS MICROCYN WOUND GEL is FRO. This falls under the Anesthesiology category.

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Other records listing Oculus Innovative Sciences, 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.

K102945PEDIACYN ATOPIC DERMATITIS HYDROGELK093585MICROCYN SKIN AND WOUND HYDROGELK090206OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSERK060113DERMACYN WOUND CAREK042729DERMACYN WOUND IRRIGATIONK041161MICROCYN WOUND CARE DRESSING

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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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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