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FDA 510(k)

NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER

K-Number: K113820 · 2012-08-08

ApplicantNovabay Pharmaceuticals
Decision Date2012-08-08
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER is the device name listed in this FDA 510(k) record. The listed applicant is Novabay Pharmaceuticals. It received FDA 510(k) clearance on 2012-08-08 under 510(k) number K113820. 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 NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER?

NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER is a medical device that received FDA 510(k) clearance on 2012-08-08. The listed applicant is Novabay Pharmaceuticals. The 510(k) number is K113820.

When did NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER receive FDA 510(k) clearance?

NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER received FDA 510(k) clearance on 2012-08-08, under 510(k) number K113820.

Who is the listed applicant for NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER?

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

What is the FDA product code for NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER?

The FDA product code for NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER is FRO. This falls under the Anesthesiology category.

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Other records listing Novabay Pharmaceuticals 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.

K081009NEUTROPHASEK071056NEUTROPHASE WOUND CLEANSER

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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