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FDA 510(k)

NEUTROPHASE WOUND CLEANSER

K-Number: K071056 · 2007-09-28

ApplicantNovabay Pharmaceuticals
Decision Date2007-09-28
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

NEUTROPHASE 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 2007-09-28 under 510(k) number K071056. 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 WOUND CLEANSER?

NEUTROPHASE WOUND CLEANSER is a medical device that received FDA 510(k) clearance on 2007-09-28. The listed applicant is Novabay Pharmaceuticals. The 510(k) number is K071056.

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

NEUTROPHASE WOUND CLEANSER received FDA 510(k) clearance on 2007-09-28, under 510(k) number K071056.

Who is the listed applicant for NEUTROPHASE 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 WOUND CLEANSER?

The FDA product code for NEUTROPHASE WOUND CLEANSER 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.

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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.

K113820NEUTROPHASE ANTIMICROBIAL WOUND CLEANSERK081009NEUTROPHASE

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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