NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER— 510(k) K113820

Name: FDA 510(k) clearance K113820
Creator: U.S. Food and Drug Administration
Published: 2012-08-08

Substantially Equivalent

Novabay Pharmaceuticals

FDA 510(k) clearance K113820 for NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER, Substantially Equivalent on 2012-08-08. Applicant: Novabay Pharmaceuticals. Device class: Unclassified.

Clearance details

Applicant: Novabay Pharmaceuticals
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-12-27
Decision date: 2012-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Altos, CA, US

Download summary PDF View on FDA.gov ↗

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K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.